{"id":23423,"date":"2025-12-04T15:20:12","date_gmt":"2025-12-04T18:20:12","guid":{"rendered":"https:\/\/sobelconsult.com\/materiais\/br-fda-compliance-issues\/"},"modified":"2026-05-24T20:24:40","modified_gmt":"2026-05-24T23:24:40","slug":"br-fda-compliance-issues","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/es\/materiais\/br-fda-compliance-issues\/","title":{"rendered":"br-fda-compliance-issues"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"23423\" class=\"elementor elementor-23423 elementor-23386\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-39723b2b e-flex e-con-boxed e-con e-parent\" data-id=\"39723b2b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-6c688f8d e-con-full e-flex e-con e-child\" data-id=\"6c688f8d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3d0f611a elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"3d0f611a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"741\" height=\"290\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-BlueSea.webp\" class=\"attachment-full size-full wp-image-8311\" alt=\"Logo Sobel\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3727f9c8 elementor-align-left elementor-widget elementor-widget-button\" data-id=\"3727f9c8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-pulse\" href=\"#cta\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<i aria-hidden=\"true\" class=\" ti-location-arrow\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Fale com a Sobel<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2a1b2ace e-con-full e-flex e-con e-child\" data-id=\"2a1b2ace\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7453b850 elementor-widget elementor-widget-heading\" data-id=\"7453b850\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Estados Unidos - FDA - Conformidad y Sistema de Calidad<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1c8a67b9 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"1c8a67b9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Problemas de Conformidad FDA - <span>Investigaci\u00f3n y Soluci\u00f3n<\/span><\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-568246f1 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"568246f1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Traducimos lo que dice la FDA, conectamos los resultados a las acciones del sistema de calidad, dise\u00f1amos y documentamos el plan de remediaci\u00f3n y apoiamos sus respuestas - para salir del modo \"apagar el incendio\" y avanzar con un plan controlado y cr\u00edtico.<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5f11bb3e elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"5f11bb3e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Achados da FDA pesam: El formulario 483, la carta de advertencia, la carta sin t\u00edtulo, las reuniones de encerrona de inspecci\u00f3n, las retenciones de importaci\u00f3n o las observaciones repetidas pueden hacer fracasar los proyectos y consumir recursos. En la pr\u00e1ctica, el problema rara vez es una \u00fanica observaci\u00f3n: es el conjunto de lagunas del sistema de calidad y la falta de un plano de remediaci\u00f3n estruturado y defendible. <\/p><p>Ayudamos a entender las preguntas en un lenguaje claro, a mapear observaciones para requisitos espec\u00edficos (por ejemplo, 21 CFR 820, Parte 803\/806, expectativas de integridad de datos), a priorizar riesgos y a construir un plan de reparaci\u00f3n y CAPA con respuestas y pasos definidos. A continuaci\u00f3n, apoyamos la redacci\u00f3n de las respuestas y el acompa\u00f1amiento de la implementaci\u00f3n, para que tu retorno a la FDA sea coherente y est\u00e9 respaldado por acciones reales. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-21dd37b0 e-con-full e-flex e-con e-child\" data-id=\"21dd37b0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-3e9d459f e-con-full e-flex e-con e-child\" data-id=\"3e9d459f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ac69c29 elementor-widget elementor-widget-text-editor\" data-id=\"ac69c29\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Resposta a Form 483 &amp; Carta de Advertencia<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-653eb713 e-con-full e-flex e-con e-child\" data-id=\"653eb713\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-61454b57 elementor-widget elementor-widget-text-editor\" data-id=\"61454b57\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Planejamento de CAPA &amp; remedia\u00e7\u00e3o<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4b04ca96 e-con-full e-flex e-con e-child\" data-id=\"4b04ca96\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-15a5a2eb elementor-widget elementor-widget-text-editor\" data-id=\"15a5a2eb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Evaluaci\u00f3n de lagunas de SGQ (21 CFR 820 \/ ISO 13485)<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7a906c1 e-con-full e-flex e-con e-child\" data-id=\"7a906c1\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-63c087e4 elementor-widget elementor-widget-text-editor\" data-id=\"63c087e4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Alinhamento de p\u00f3s-mercado &amp; reporte<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-11f97eaf elementor-align-left borda-piscando elementor-widget elementor-widget-button\" data-id=\"11f97eaf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-pulse\" href=\"#cta\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-envelope\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 64H48C21.49 64 0 85.49 0 112v288c0 26.51 21.49 48 48 48h416c26.51 0 48-21.49 48-48V112c0-26.51-21.49-48-48-48zm0 48v40.805c-22.422 18.259-58.168 46.651-134.587 106.49-16.841 13.247-50.201 45.072-73.413 44.701-23.208.375-56.579-31.459-73.413-44.701C106.18 199.465 70.425 171.067 48 152.805V112h416zM48 400V214.398c22.914 18.251 55.409 43.862 104.938 82.646 21.857 17.205 60.134 55.186 103.062 54.955 42.717.231 80.509-37.199 103.053-54.947 49.528-38.783 82.032-64.401 104.947-82.653V400H48z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Estabilizar mi situaci\u00f3n con la FDA<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6cb7fdd0 elementor-widget elementor-widget-spacer\" data-id=\"6cb7fdd0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-406cf8d0 e-con-full e-transform e-flex e-con e-parent\" data-id=\"406cf8d0\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;_transform_translateX_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:-48,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-40b1a613 elementor-widget elementor-widget-image-carousel\" data-id=\"40b1a613\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;slides_to_show&quot;:&quot;7&quot;,&quot;slides_to_scroll&quot;:&quot;1&quot;,&quot;navigation&quot;:&quot;none&quot;,&quot;autoplay_speed&quot;:3000,&quot;speed&quot;:1500,&quot;image_spacing_custom&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:4,&quot;sizes&quot;:[]},&quot;slides_to_show_mobile&quot;:&quot;2&quot;,&quot;autoplay&quot;:&quot;yes&quot;,&quot;pause_on_hover&quot;:&quot;yes&quot;,&quot;pause_on_interaction&quot;:&quot;yes&quot;,&quot;infinite&quot;:&quot;yes&quot;,&quot;image_spacing_custom_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;image_spacing_custom_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;image_spacing_custom_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"image-carousel.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-image-carousel-wrapper swiper\" role=\"region\" aria-roledescription=\"carousel\" aria-label=\"Image Carousel\" dir=\"ltr\">\n\t\t\t<div class=\"elementor-image-carousel swiper-wrapper\" aria-live=\"off\">\n\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"1 de 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client2-Sobel-rny9633u5xltwukdgukolqwxnhur2mvqo5jefy8274.webp\" alt=\"CMOS DRAKE logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"2 de 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client3-Sobel-rny9a8k6claf6uja856d47783re42id28p9lqy2gps.webp\" alt=\"Baruel Logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"3 de 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client4-Sobel-rnz4k1t7z2fwtb8a9s62j3s9rqelbprdoyfofstc80.webp\" alt=\"Generate logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"4 de 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client5-Sobel-rnz4k4mqjkjrs546tbdy8l2njw0oyt2kpce4vmp5pc.webp\" alt=\"Ortosintese logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"5 de 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client6-Sobel-rny5l5ksq13xedugc48xla6satc99916y03qnle3og.webp\" alt=\"ZSI logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"6 de 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client7-Sobel-rny63jb6de9sfv5902aacn7ai2qns6084zdkie4y00.webp\" alt=\"Medtronic logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"7 de 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client8-Sobel-rny6aardjhj1yvbmihinsfrocveq5rupegcbt23z8g.webp\" alt=\"Braun logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"8 de 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client9-Sobel-rny70glnrhcd45bjqsmu6u3jkygiehpqzy0uobbi1s.webp\" alt=\"Hypera Pharma logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"9 de 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client10-Sobel-rny7cbcdy9kjj43oix3gmuet9w15h2rvym7ajxqrkw.webp\" alt=\"M Vision logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"10 de 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client1-Sobel-rny90rcrfqbc4eawkjosh3awgw3vgdqhxsgcji4dgg.webp\" alt=\"Andratec logo\" \/><\/figure><\/div>\t\t\t<\/div>\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7fac08bc e-flex e-con-boxed e-con e-parent\" data-id=\"7fac08bc\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-4fba0fef e-con-full e-flex e-con e-child\" data-id=\"4fba0fef\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4bd9773f elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"4bd9773f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Cuando el Suporte em Conformidade FDA Faz Sentido<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5ea8d775 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"5ea8d775\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Situa\u00e7\u00f5es t\u00edpicas em que um suporte externo estruturado muda a trajet\u00f3ria:\"}]\" data-inline-monday=\"true\">Situaciones t\u00edpicas en las que un suporte externo estruturado muda a la trajet\u00f3ria:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2ee5a7d8 e-con-full e-flex e-con e-child\" data-id=\"2ee5a7d8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2902038d elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"2902038d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Has recibido un formulario 483, una carta de advertencia o una carta sin t\u00edtulo de la FDA y tienes que responder en plazo.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Hay observaciones repetidas en inspecciones o auditor\u00edas (internas, MDSAP, organismo notificado) y es preciso romper el ciclo.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Las auditor\u00edas internas, las reclamaciones o las acciones de campo indican que la FDA probablemente encuentre problemas sist\u00e9micos si se inspecciona ahora.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Un cliente o parceiro cr\u00edtico te pregunta c\u00f3mo cumples las expectativas de la FDA y quiere ver un plano concreto.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Tu tiempo de calidad\/regulaci\u00f3n est\u00e1 sobrecargado y no puedes, al mismo tiempo, operar el sistema y dise\u00f1ar un proyecto robusto de reparaci\u00f3n.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7a5f8c12 e-flex e-con-boxed e-con e-parent\" data-id=\"7a5f8c12\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3c05014a elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"3c05014a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Lo que vas a recibir<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-73de61ae elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"73de61ae\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"O resultado \u00e9 uma vis\u00e3o estruturada dos seus problemas de conformidade, um plano de remedia\u00e7\u00e3o e CAPA priorizado e documenta\u00e7\u00e3o de suporte clara para o di\u00e1logo com a FDA e clientes cr\u00edticos.\"}]\" data-inline-monday=\"true\">El resultado es una visi\u00f3n estructurada de sus problemas de conformidad, un plan de correcci\u00f3n y CAPA priorizado y documentaci\u00f3n de apoyo clara para el di\u00e1logo con la FDA y los clientes cr\u00edticos.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17d8fb4f elementor-align-left borda-piscando elementor-widget elementor-widget-button\" data-id=\"17d8fb4f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-pulse\" href=\"#cta\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-envelope\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 64H48C21.49 64 0 85.49 0 112v288c0 26.51 21.49 48 48 48h416c26.51 0 48-21.49 48-48V112c0-26.51-21.49-48-48-48zm0 48v40.805c-22.422 18.259-58.168 46.651-134.587 106.49-16.841 13.247-50.201 45.072-73.413 44.701-23.208.375-56.579-31.459-73.413-44.701C106.18 199.465 70.425 171.067 48 152.805V112h416zM48 400V214.398c22.914 18.251 55.409 43.862 104.938 82.646 21.857 17.205 60.134 55.186 103.062 54.955 42.717.231 80.509-37.199 103.053-54.947 49.528-38.783 82.032-64.401 104.947-82.653V400H48z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Falar com um especialista<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5c14cd67 e-flex e-con-boxed e-con e-parent\" data-id=\"5c14cd67\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-60d5e9eb e-con-full e-flex e-con e-child\" data-id=\"60d5e9eb\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6ad0ea16 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"6ad0ea16\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Mapa de problemas y visi\u00f3n de riesgo regulatorio<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bddaf64 elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-text-editor\" data-id=\"bddaf64\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" Preparation and support for UDI\/Devices entries using your existing Basic UDI-DI, UDI-DI, UDI-PI, and Annex VI data. We structure your information for the module, highlight obvious inconsistencies, and guide you through entering and saving records in EUDAMED.\"}]\" data-inline-monday=\"true\">Preparaci\u00f3n y apoyo para las entradas de UDI\/Dispositivos utilizando tus datos existentes de UDI-DI B\u00e1sico, UDI-DI, UDI-PI y Anexo VI. Estructuramos tu informaci\u00f3n para el m\u00f3dulo, destacamos las incoherencias evidentes y te guiamos para que introduzcas y guardes los registros en EUDAMED. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2c014c3c elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"2c014c3c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Resumen en lenguaje sencillo de los informes de la FDA (formulario 483, carta de advertencia, informe de inspecci\u00f3n, correspondencia), elaborados para reglamentos y gu\u00edas espec\u00edficos.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Agrupamiento de observaciones en temas (por ejemplo, CAPA, tratamiento de reclamaciones, control de proyecto, controles de producci\u00f3n, p\u00f3s-mercado\/reporte, integridad de datos).<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Visi\u00f3n de riesgo regulatorio de alto nivel: lo que es sist\u00e9mico vs. pontual y d\u00f3nde se centrar\u00e1 probablemente la FDA para seguir.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c25d7f e-con-full e-flex e-con e-child\" data-id=\"c25d7f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1a3c9fd6 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"1a3c9fd6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Plan de Remediaci\u00f3n y CAPA<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3030a55 elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-text-editor\" data-id=\"3030a55\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" Preparation and support for UDI\/Devices entries using your existing Basic UDI-DI, UDI-DI, UDI-PI, and Annex VI data. We structure your information for the module, highlight obvious inconsistencies, and guide you through entering and saving records in EUDAMED.\"}]\" data-inline-monday=\"true\">Preparaci\u00f3n y apoyo para las entradas de UDI\/Dispositivos utilizando tus datos existentes de UDI-DI B\u00e1sico, UDI-DI, UDI-PI y Anexo VI. Estructuramos tu informaci\u00f3n para el m\u00f3dulo, destacamos las incoherencias evidentes y te guiamos para que introduzcas y guardes los registros en EUDAMED. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6ae58390 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"6ae58390\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Roteiro de remedia\u00e7\u00e3o priorizado, com a\u00e7\u00f5es claras, respons\u00e1veis, prazos e depend\u00eancias.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Estrutura de CAPA (Corre\u00e7\u00e3o e A\u00e7\u00e3o Preventiva) ligando: problema \u2192 causa raiz \u2192 conten\u00e7\u00e3o \u2192 a\u00e7\u00f5es corretivas \u2192 verifica\u00e7\u00e3o de efic\u00e1cia.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Alinhamento das a\u00e7\u00f5es de remedia\u00e7\u00e3o com a arquitetura do SGQ (procedimentos, registros, treinamentos, sistemas de TI).<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Visibilidad de las \"victorias r\u00e1pidas\" frente a los cambios m\u00e1s profundos del sistema, para que la direcci\u00f3n entienda el esfuerzo y el riesgo.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-40c18021 e-con-full e-flex e-con e-child\" data-id=\"40c18021\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-401dda33 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"401dda33\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Rascunhos de Resposta &amp; Documenta\u00e7\u00e3o de Suporte<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3d008d09 elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-text-editor\" data-id=\"3d008d09\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" Preparation and support for UDI\/Devices entries using your existing Basic UDI-DI, UDI-DI, UDI-PI, and Annex VI data. We structure your information for the module, highlight obvious inconsistencies, and guide you through entering and saving records in EUDAMED.\"}]\" data-inline-monday=\"true\">Preparaci\u00f3n y apoyo para las entradas de UDI\/Dispositivos utilizando tus datos existentes de UDI-DI B\u00e1sico, UDI-DI, UDI-PI y Anexo VI. Estructuramos tu informaci\u00f3n para el m\u00f3dulo, destacamos las incoherencias evidentes y te guiamos para que introduzcas y guardes los registros en EUDAMED. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-24499d7e elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"24499d7e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Apoyo en la elaboraci\u00f3n y redacci\u00f3n de respuestas a la FDA (y, cuando proceda, a clientes o socios), utilizando los insumos t\u00e9cnicos y factuales de tu equipo.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">V\u00ednculo claro entre cada observaci\u00f3n y su CAPA correspondiente, con pruebas de aplicaci\u00f3n.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Modelos para actualizaciones de progreso y comunicaciones de seguimiento, manteniendo la narrativa consistente a lo largo de la implementaci\u00f3n.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-402f9a8 e-con-full e-flex e-con e-child\" data-id=\"402f9a8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f681bca elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"f681bca\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Gobernanza del Proyecto y Acompa\u00f1amiento<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1e26555 elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-text-editor\" data-id=\"1e26555\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" Preparation and support for UDI\/Devices entries using your existing Basic UDI-DI, UDI-DI, UDI-PI, and Annex VI data. We structure your information for the module, highlight obvious inconsistencies, and guide you through entering and saving records in EUDAMED.\"}]\" data-inline-monday=\"true\">Preparaci\u00f3n y apoyo para las entradas de UDI\/Dispositivos utilizando tus datos existentes de UDI-DI B\u00e1sico, UDI-DI, UDI-PI y Anexo VI. Estructuramos tu informaci\u00f3n para el m\u00f3dulo, destacamos las incoherencias evidentes y te guiamos para que introduzcas y guardes los registros en EUDAMED. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-de16f46 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"de16f46\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Modelo simple de gobernanza: papeles y responsabilidades, pontos de escalonamento e cad\u00eancia de reporte.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Visiones de acompa\u00f1amiento (por ejemplo, rastreadores de acciones, registro de riesgos) que la direcci\u00f3n realmente consiga utilizar.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Pontos de controle opcionais para revis\u00e3o de status antes de marcos-chave (prazo de resposta \u00e0 FDA, reinspe\u00e7\u00e3o, auditoria de cliente).<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-238c580d elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile e-flex e-con-boxed e-con e-parent\" data-id=\"238c580d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-13794b71 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"13794b71\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Registros de dispositivos registrados en EUDAMED utilizando tus propios identificadores y datos.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b6529b8 elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"b6529b8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ucaddon_horizontal_timeline.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\n<!-- start Horizontal Timeline -->\n\t\t<link id='font-awesome-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/font-awesome6\/fontawesome-all.min.css' type='text\/css' rel='stylesheet' >\n\t\t<link id='font-awesome-4-shim-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/font-awesome6\/fontawesome-v4-shims.min.css' type='text\/css' rel='stylesheet' >\n\t\t<link id='owl-carousel-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/owl-carousel-new\/assets\/owl.carousel.css' type='text\/css' rel='stylesheet' >\n\n<style>\/* widget: Horizontal Timeline *\/\n\n#uc_horizontal_timeline_elementor_b6529b8 *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_b6529b8{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_b6529b8 .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_b6529b8  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_b6529b8  .carousel-nav button i{\n  position: absolute;\n     top: 50%;\n  left: 50%;\n  transform: translate(-50%, -50%);\n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .ue-item-bullet i, #uc_horizontal_timeline_elementor_b6529b8 .ue-item-bullet svg{\n  position: absolute;\n  top: 50%;\n  left: 50%;\n  transform: translate(-50%, -50%); \n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_b6529b8 .ue-carousel-item-holder{\n  display: flex;\n  flex-direction: column;\n  align-items: stretch;\n  height:100%;\n}\n\n<\/style>\n\n<div class=\"ue-horizontal-timeline\" id=\"uc_horizontal_timeline_elementor_b6529b8\">\n     <div class=\"carousel-nav\">\n            <button class=\"carousel-prev\" aria-label=\"Previous\">\n                <i class=' ti-arrow-circle-left'><\/i>\n            <\/button>\n            <button class=\"carousel-next\" aria-label=\"Next\">\n                <i class=' ti-arrow-circle-right'><\/i>\n            <\/button>\n        <\/div>\n    <div class=\"owl-carousel owl-theme uc-items-wrapper item-horizontal-timeline  \" id=\"uc_horizontal_timeline_elementor_b6529b8\" data-custom-sethtml=\"true\"  >\n     \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-5a1769b\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Confirmar actores y SRN<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\"><\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-5f58639\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Utiliza tus datos UDI y del Anexo VI existentes<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\"><\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-acf916a\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Preparar entradas UDI\/Dispositivos<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\"><\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-d99b48f\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Actualizaciones y mantenimiento del plan<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\"><\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n\n  <\/div>\n<\/div>\n<!-- end Horizontal Timeline -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3da6015b elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile e-flex e-con-boxed e-con e-parent\" data-id=\"3da6015b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-11bc1a01 e-con-full e-flex e-con e-child\" data-id=\"11bc1a01\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-104c8d85 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"104c8d85\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Etiqueta y confirmaci\u00f3n IFU<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-76727112 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"76727112\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Comprueba que la identificaci\u00f3n BRH aparece correctamente en las etiquetas y las IFU, seg\u00fan sea necesario.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Apoyo a la carga electr\u00f3nica del portal IFU cuando proceda.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Alineaci\u00f3n b\u00e1sica del texto normativo de las etiquetas\/IFU con los registros\/notificaciones concedidos.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4c3706e5 e-con-full e-flex e-con e-child\" data-id=\"4c3706e5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-67bd4834 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"67bd4834\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Plan de Cambio y Revalidaci\u00f3n<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-58b1ce4f elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"58b1ce4f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Categorizar los cambios posteriores a la homologaci\u00f3n (necesarios para la homologaci\u00f3n, de aplicaci\u00f3n inmediata, no notificables) en el RDC 751\/2022.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Mant\u00e9n un calendario y una l\u00f3gica de seguimiento para la validez y revalidaci\u00f3n del registro durante 10 a\u00f1os.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Esboza un modelo sencillo de gobernanza para que los equipos t\u00e9cnicos y comerciales sepan cu\u00e1ndo implicar al BRH.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-97b04db e-con-full e-flex e-con e-child\" data-id=\"97b04db\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-731546e8 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"731546e8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Vigilancia y Acciones de Campo Enrutamiento<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78d7dba5 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"78d7dba5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Define qui\u00e9n informa de qu\u00e9, a qui\u00e9n y cu\u00e1ndo para las se\u00f1ales de vigilancia y las acciones de campo espec\u00edficas de Brasil.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Aclarar los plazos y las funciones para las notificaciones de la ANVISA, las comunicaciones a los clientes y los informes de seguimiento.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Garantizar que la documentaci\u00f3n de vigilancia respalda las obligaciones de registro y etiquetado.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6065c051 e-flex e-con-boxed e-con e-parent\" data-id=\"6065c051\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-6d060449 e-con-full e-flex e-con e-child\" data-id=\"6d060449\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-68e32579 e-con-full e-flex e-con e-child\" data-id=\"68e32579\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-49146eec elementor-widget elementor-widget-heading\" data-id=\"49146eec\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">C\u00f3mo resolver sus problemas de conformidad con la FDA<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1f75fe72 elementor-widget elementor-widget-text-editor\" data-id=\"1f75fe72\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Partimos dos achados que voc\u00ea j\u00e1 tem e constru\u00edmos em torno deles um projeto de remedia\u00e7\u00e3o realista e defens\u00e1vel.\"}]\" data-inline-monday=\"true\">Partimos de los logros que ya tienes y construimos en torno a ellos un proyecto de reparaci\u00f3n realista y defendible.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1115eab8 elementor-align-left borda-piscando elementor-widget elementor-widget-button\" data-id=\"1115eab8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-pulse\" href=\"#cta\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-envelope\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 64H48C21.49 64 0 85.49 0 112v288c0 26.51 21.49 48 48 48h416c26.51 0 48-21.49 48-48V112c0-26.51-21.49-48-48-48zm0 48v40.805c-22.422 18.259-58.168 46.651-134.587 106.49-16.841 13.247-50.201 45.072-73.413 44.701-23.208.375-56.579-31.459-73.413-44.701C106.18 199.465 70.425 171.067 48 152.805V112h416zM48 400V214.398c22.914 18.251 55.409 43.862 104.938 82.646 21.857 17.205 60.134 55.186 103.062 54.955 42.717.231 80.509-37.199 103.053-54.947 49.528-38.783 82.032-64.401 104.947-82.653V400H48z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Estabilizar mi situaci\u00f3n con la FDA<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-211b685a e-con-full e-flex e-con e-child\" data-id=\"211b685a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-31b1932 elementor-widget elementor-widget-image\" data-id=\"31b1932\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"2560\" height=\"1440\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-scaled.jpg\" class=\"attachment-full size-full wp-image-15535\" alt=\"A healthcare professional&apos;s office. A laptop displays test results.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-scaled.jpg 2560w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-300x169.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-1024x576.jpg 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-768x432.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-1536x864.jpg 1536w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-2048x1152.jpg 2048w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-21d93759 e-con-full e-flex e-con e-child\" data-id=\"21d93759\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-30f861a7 e-con-full e-flex e-con e-child\" data-id=\"30f861a7\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7747c187 elementor-widget elementor-widget-heading\" data-id=\"7747c187\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">01<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4cb32c30 elementor-widget elementor-widget-heading\" data-id=\"4cb32c30\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Ingesta &amp; Leitura de Cen\u00e1rio<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-23c4746f elementor-widget elementor-widget-heading\" data-id=\"23c4746f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">Revisamos formularios 483, cartas de advertencia, informes de infracci\u00f3n, auditor\u00edas internas, informes de reclamaciones y respuestas anteriores. Entendemos tu contexto de neg\u00f3cio, apetito de risco y prazos cr\u00edticos. <\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-54293eec elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"54293eec\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Confirma tu acceso a la cuenta GUDID (remitente\/coordinador) y tu funci\u00f3n de etiquetador.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Recopila tu informaci\u00f3n UDI (DI existente y organismo emisor) y una lista de productos con atributos b\u00e1sicos y niveles de envasado.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-79f656ea elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"79f656ea\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-51df4a06 e-con-full e-flex e-con e-child\" data-id=\"51df4a06\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-110dd92a elementor-widget elementor-widget-heading\" data-id=\"110dd92a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">02<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1ef0a1c4 elementor-widget elementor-widget-heading\" data-id=\"1ef0a1c4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Orienta\u00e7\u00e3o de Lacunas &amp; Causa Raiz<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-60fd9ac9 elementor-widget elementor-widget-heading\" data-id=\"60fd9ac9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">Realizamos observaciones para 21 CFR 820, 803, 806 y expectativas relevantes. Diferenciamos los fallos locales de los problemas sist\u00e9micos. Alinhamos hip\u00f3teses realistas de causa raiz antes de sobrecargar CAPAs.  <\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-404fe080 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"404fe080\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Asigna tu UDI y los detalles del producto a la estructura de datos GUDID.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Marca los elementos esenciales que falten para que los confirmes o corrijas.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-57b136a7 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"57b136a7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-48307cd8 e-con-full e-flex e-con e-child\" data-id=\"48307cd8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f1f4367 elementor-widget elementor-widget-heading\" data-id=\"f1f4367\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">03<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1402e998 elementor-widget elementor-widget-heading\" data-id=\"1402e998\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Dise\u00f1o de Remediaci\u00f3n y CAPA<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-34703cc5 elementor-widget elementor-widget-heading\" data-id=\"34703cc5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">Dise\u00f1amos un plan de correcci\u00f3n integrado en tu SGQ: cambios de procedimiento, actualizaci\u00f3n de registros, tratamientos, ajustes de sistema\/TI y refuerzo de la supervisi\u00f3n. Elaboramos CAPA estrictos que la FDA y los clientes recomiendan seguir. <\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-82ae71b elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"82ae71b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Accede a tu cuenta web GUDID e introduce los registros DI en tu nombre.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Rellena los campos obligatorios y guarda las entradas para que aparezcan en GUDID y AccessGUDID.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-601a01de elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"601a01de\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-364df3d8 e-con-full e-flex e-con e-child\" data-id=\"364df3d8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6f0c9c28 elementor-widget elementor-widget-heading\" data-id=\"6f0c9c28\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">04<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2d4a4c81 elementor-widget elementor-widget-heading\" data-id=\"2d4a4c81\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Reducci\u00f3n de costes y comunicaci\u00f3n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5247835d elementor-widget elementor-widget-heading\" data-id=\"5247835d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">Ayudamos a estructurar y reconstruir respuestas formales, conectando cada afirmaci\u00f3n a hechos y pruebas concretos. Alinhamos mensagens internas e externas para que todos contemplem a mesma hist\u00f3ria. <\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4a48c75d elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"4a48c75d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Proporcionarte una lista sencilla de los DI registrados y los atributos clave introducidos.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Comparte una breve lista de comprobaci\u00f3n para a\u00f1adir o actualizar DIs por tu cuenta en el futuro.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-75238c27 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"75238c27\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-256a9dde e-con-full e-flex e-con e-child\" data-id=\"256a9dde\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-2526351a e-con-full e-flex e-con e-child\" data-id=\"2526351a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5b2909f6 elementor-widget elementor-widget-heading\" data-id=\"5b2909f6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">05<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-72856bf0 elementor-widget elementor-widget-heading\" data-id=\"72856bf0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Apoyo a la Implantaci\u00f3n y Preparaci\u00f3n para la Reinserci\u00f3n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-48e10f1c elementor-widget elementor-widget-heading\" data-id=\"48e10f1c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">Realizamos revisiones peri\u00f3dicas de progreso, documentaci\u00f3n y pruebas. Cuando es necesario, preparamos al equipo para reinspecciones o auditor\u00edas de clientes, bas\u00e1ndonos en la narrativa de remediaci\u00f3n acordada. <\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1a08a590 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"1a08a590\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-62964b2d animated-slow e-con-full elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile e-flex elementor-invisible e-con e-parent\" data-id=\"62964b2d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3b944c3b elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"3b944c3b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Lo que necesitamos de ti<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5f9a38b8 elementor-widget-laptop__width-initial elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"5f9a38b8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" We rely on you as the labeler for UDI choices and product facts; we handle the data entry.\"}]\" data-inline-monday=\"true\">Confiamos en ti como etiquetador para las opciones UDI y los datos del producto; nosotros nos encargamos de la introducci\u00f3n de datos.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-791aea28 e-flex e-con-boxed e-con e-child\" data-id=\"791aea28\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-4e49d5ca e-con-full e-flex e-con e-child\" data-id=\"4e49d5ca\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-78748b68 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"78748b68\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Datos de la cuenta GUDID y confirmaci\u00f3n de que puedes concedernos acceso\/uso seg\u00fan tus normas internas.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Valores de DI existentes y organismo emisor (GS1, HIBCC, ICCBBA, etc.-t\u00fa eliges).<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Lista de productos: marca, modelo\/versi\u00f3n, niveles de envasado y algunos atributos clave (por ejemplo, est\u00e9ril, de un solo uso, kit\/sistema).<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Si estamos actualizando DIs existentes: un breve registro de cambios y la confirmaci\u00f3n de que las ediciones est\u00e1n permitidas.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Un \u00fanico contacto regulador\/de calidad para preguntas sobre datos.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-432f3111 elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-text-editor\" data-id=\"432f3111\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Consulting and documentation support only. We do not design UDI schemes, do not create Annex VI data, do not select issuing agencies, and do not act as a notified body, importer, or label designer. You remain responsible for UDI assignment, Annex VI content, technical documentation, and all formal submissions in EUDAMED.\"}]\" data-inline-monday=\"true\">S\u00f3lo asesoramiento y apoyo documental. No dise\u00f1amos esquemas UDI, no creamos datos del anexo VI, no seleccionamos organismos emisores y no actuamos como organismo notificado, importador o dise\u00f1ador de etiquetas.  Sigues siendo responsable de la asignaci\u00f3n de UDI, del contenido del Anexo VI, de la documentaci\u00f3n t\u00e9cnica y de todas las presentaciones formales en EUDAMED.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7ca1080 animated-slow e-con-full e-flex elementor-invisible e-con e-parent\" data-id=\"7ca1080\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-47bcf770 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"47bcf770\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Escopo y Limitaciones<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7cda95aa elementor-widget-laptop__width-initial elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"7cda95aa\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Mantemos fronteiras claras para que as responsabilidades entre sua organiza\u00e7\u00e3o, a Sobel e a FDA fiquem bem definidas.\"}]\" data-inline-monday=\"true\">Mantengamos las fronteras claras para que las responsabilidades entre tu organizaci\u00f3n, Sobel y la FDA est\u00e9n bien definidas.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5eda3a07 e-flex e-con-boxed e-con e-child\" data-id=\"5eda3a07\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-4699b16a e-con-full e-flex e-con e-child\" data-id=\"4699b16a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3af33108 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"3af33108\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Dentro do Escopo<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-11f8c04f elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"11f8c04f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Consultor\u00eda y soporte documental para problemas de conformidad FDA (Formularios 483, Cartas de Advertencia, observaciones de inspecci\u00f3n).<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Realizaci\u00f3n de observaciones para reglamentos y expectativas aplicables (por ejemplo, 21 CFR 820, tratamiento de reclamaciones, informe, CAPA).<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Dise\u00f1o y documentaci\u00f3n de planos de reparaci\u00f3n y CAPA, utilizando sus procesos e insumos t\u00e9cnicos.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Evaluaci\u00f3n de las lagunas de alto nivel del SGQ, en l\u00ednea con las expectativas de la FDA y, si procede, de la ISO 13485\/MDSAP.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Apoyo en la redacci\u00f3n de respuestas a la FDA y a los clientes, basadas en hechos y pruebas aportadas por ti.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Coordinaci\u00f3n con \u00e1reas internas y externas (laboratorios, asesor\u00eda jur\u00eddica, otros asesores) dentro del \u00e1mbito del proyecto de remediaci\u00f3n.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2ecce48a e-con-full e-flex e-con e-child\" data-id=\"2ecce48a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-40eb8904 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"40eb8904\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Fora do Escopo<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-37f6365f elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"37f6365f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Atuar como a pr\u00f3pria FDA ou tomar decis\u00f5es regulat\u00f3rias em nome da ag\u00eancia.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Atuar como seu advogado ou fornecer opini\u00e3o jur\u00eddica; trabalhamos em conjunto com seu jur\u00eddico quando necess\u00e1rio.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">\"Carimbar\" respostas existentes sem nenhuma a\u00e7\u00e3o ou evid\u00eancia por tr\u00e1s.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Realizar ensayos de laboratorio o trabajos de campo directamente (podemos ayudar a especificar y planificar).<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Asume el papel de Fabricante Legal; la responsabilidad por la conformidad y por el acabado final permanece con tu organizaci\u00f3n.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-39fe5d05 e-con-full e-flex e-con e-child\" data-id=\"39fe5d05\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-efd7891 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"efd7891\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Informaci\u00f3n que necesitamos de tu tiempo<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1900ee40 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"1900ee40\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">C\u00f3pias da correspond\u00eancia com a FDA (Formularios 483, Cartas de advert\u00eancia, relat\u00f3rios de inspe\u00e7\u00e3o, e-mails relevantes).<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Documentos del SGQ relacionados con los logros (POPs\/SOPs, instrucciones de trabajo, formularios, plantillas).<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Ejemplos de registros (CAPAs, reclama\u00e7\u00f5es, registros de lote, relat\u00f3rios de valida\u00e7\u00e3o, registros de treinamento etc.).<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Informaci\u00f3n organizativa: funciones, sitios y \u00e1reas implicadas en la b\u00fasqueda.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Restricciones y prioridades (por ejemplo, productos\/mercados que no se pueden intercambiar, compromisos cr\u00edticos con los clientes).<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7700ed0c elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-text-editor\" data-id=\"7700ed0c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Consulting and documentation support only. We do not design UDI schemes, do not create Annex VI data, do not select issuing agencies, and do not act as a notified body, importer, or label designer. You remain responsible for UDI assignment, Annex VI content, technical documentation, and all formal submissions in EUDAMED.\"}]\" data-inline-monday=\"true\">S\u00f3lo asesoramiento y apoyo documental. No dise\u00f1amos esquemas UDI, no creamos datos del anexo VI, no seleccionamos organismos emisores y no actuamos como organismo notificado, importador o dise\u00f1ador de etiquetas.  Sigues siendo responsable de la asignaci\u00f3n de UDI, del contenido del Anexo VI, de la documentaci\u00f3n t\u00e9cnica y de todas las presentaciones formales en EUDAMED.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2d543ac6 elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile e-flex e-con-boxed e-con e-parent\" data-id=\"2d543ac6\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-26d24440 e-con-full e-flex e-con e-child\" data-id=\"26d24440\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6eb94c99 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"6eb94c99\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Cu\u00e1ndo necesitas un titular de registro brasile\u00f1o<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7406a95a elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"7406a95a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Situations where a full Registro submission to ANVISA is required and where a structured pack saves time and internal effort:\"}]\" data-inline-monday=\"true\"><strong>Situaciones t\u00edpicas en las que la designaci\u00f3n de un BRH resulta esencial para el acceso al mercado brasile\u00f1o:<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1b42f07 e-con-full e-flex e-con e-child\" data-id=\"1b42f07\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7e7818e5 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"7e7818e5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Eres un fabricante extranjero de productos sanitarios sin entidad jur\u00eddica brasile\u00f1a, pero quieres colocar productos en el mercado brasile\u00f1o.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Necesitas un titular de licencia \u00fanico y estable que no est\u00e9 vinculado a ning\u00fan distribuidor, para poder mantener abiertas las opciones comerciales.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Quieres presentar notificaciones\/inscripciones con arreglo al RDC 751\/2022 y mantenerlas a lo largo del tiempo, incluidos los cambios y la revalidaci\u00f3n.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Necesitas que alguien se identifique claramente en el etiquetado\/IFU brasile\u00f1o como titular responsable ante la ANVISA.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Quieres que la vigilancia y las acciones sobre el terreno en Brasil sigan plazos y rutas definidos, sin cadenas de correo electr\u00f3nico ad hoc.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1fe4dfe8 e-flex e-con-boxed e-con e-parent\" data-id=\"1fe4dfe8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4f05018f elementor-widget elementor-widget-heading\" data-id=\"4f05018f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Preguntas frecuentes<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5a50fcc3 elementor-widget elementor-widget-toggle\" data-id=\"5a50fcc3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1511\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1511\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">\u00bfPod\u00e9is garantizar que la FDA aceite nuestra respuesta o cerrar el caso?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1511\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1511\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"N\u00e3o. S\u00f3 a FDA pode decidir se uma resposta ou plano de remedia\u00e7\u00e3o \u00e9 aceit\u00e1vel. Nosso papel \u00e9 ajudar a construir um plano cr\u00edvel, baseado em evid\u00eancias e bem apresentado \u2014 o que reduz riscos evit\u00e1veis, mas n\u00e3o garante o resultado.\"}]\" data-inline-monday=\"true\">No. S\u00f3lo la FDA puede decidir si una respuesta o un plan de remedio es adecuado. Nuestro papel es ayudar a construir un plan cr\u00edtico, basado en pruebas y bien presentado, que reduzca los riesgos evitables, pero que no garantice el resultado. <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1512\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-1512\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">\u00bfEste trabajo es s\u00f3lo sobre la carta o tambi\u00e9n sobre el sistema?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1512\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-1512\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"O foco \u00e9 o sistema. Partimos dos achados, mas o entreg\u00e1vel \u00e9 um plano de remedia\u00e7\u00e3o e CAPA que trata as causas sist\u00eamicas, n\u00e3o apenas a reda\u00e7\u00e3o da resposta.\"}]\" data-inline-monday=\"true\">El objetivo es el sistema. Partimos de los resultados, pero lo que se entrega es un plan de reparaci\u00f3n y CAPA que trata las causas sist\u00e9micas, no s\u00f3lo la redacci\u00f3n de la respuesta. <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1513\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-1513\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">\u00bfTrabaj\u00e1is a distancia o presencialmente?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1513\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-1513\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Muitas atividades (an\u00e1lise, documenta\u00e7\u00e3o, reda\u00e7\u00e3o) podem ser feitas de forma remota. Para alguns projetos \u2014 especialmente com manufatura complexa ou m\u00faltiplos sites \u2014 workshops e entrevistas presenciais podem ser recomendados e inclu\u00eddos no escopo.\"}]\" data-inline-monday=\"true\">Muchas actividades (an\u00e1lisis, documentaci\u00f3n, redacci\u00f3n) pueden realizarse a distancia. Para algunos proyectos -especialmente los de fabricaci\u00f3n compleja o de varias sedes- pueden recomendarse talleres y entrevistas presenciales. <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1514\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-1514\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">\u00bfSe conecta con la reparaci\u00f3n ISO 13485 o MDSAP?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1514\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-1514\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Com frequ\u00eancia, sim. Muitas quest\u00f5es da FDA se conectam diretamente a expectativas de ISO 13485 e MDSAP. Podemos alinhar as a\u00e7\u00f5es para que um \u00fanico esfor\u00e7o de remedia\u00e7\u00e3o atenda a m\u00faltiplos referenciais, em vez de criar projetos paralelos e conflitantes.\"}]\" data-inline-monday=\"true\">Con frecuencia, sim. Muchas preguntas de la FDA est\u00e1n directamente relacionadas con las expectativas de la ISO 13485 y el MDSAP. Podemos alinear las acciones para que un \u00fanico esfuerzo de remediaci\u00f3n atienda a m\u00faltiples referencias, en lugar de crear proyectos paralelos y conflictivos.  <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1515\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-1515\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">\u00bfPod\u00e9is entrenar al equipo despu\u00e9s de dise\u00f1ar el plan de remedio?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1515\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-1515\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Sim. Podemos apoiar no desenvolvimento e entrega de treinamentos focados sobre os processos novos ou atualizados e sobre como manter as melhorias ao longo do tempo, dentro do escopo acordado.\"}]\" data-inline-monday=\"true\">Sim. Podemos ayudar en el desarrollo y la entrega de tratamientos centrados en los procesos nuevos o actualizados y en c\u00f3mo mantener las mejoras a lo largo del tiempo, dentro del \u00e1mbito acordado. <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1b5a306c elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile e-flex e-con-boxed e-con e-parent\" data-id=\"1b5a306c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-7dd5f18c e-con-full e-flex e-con e-child\" data-id=\"7dd5f18c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6af064c3 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"6af064c3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Glosario breve<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-67a1c809 e-con-full e-flex e-con e-child\" data-id=\"67a1c809\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1fdbc90f elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"1fdbc90f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>Etiquetador:<\/strong> La parte que asigna el UDI y cuyo nombre aparece en la etiqueta del aparato; responsable de las entradas GUDID.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>GUDID (Base de datos mundial de UDI):<\/strong> La base de datos de la FDA que almacena los datos de identificaci\u00f3n de los dispositivos con UDI.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>DI (Identificador de Dispositivo):<\/strong> La parte fija del UDI que identifica al etiquetador y al modelo\/versi\u00f3n del aparato.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>PI (Identificador de producci\u00f3n):<\/strong> La parte variable del UDI (por ejemplo, lote, n\u00famero de serie, fecha de caducidad); GUDID s\u00f3lo registra qu\u00e9 PIs hay en la etiqueta, no los valores.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>AccessGUDID:<\/strong> La interfaz de b\u00fasqueda p\u00fablica que muestra los registros de dispositivos GUDID.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5a8fb650 e-flex e-con-boxed e-con e-parent\" data-id=\"5a8fb650\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-5a5846ea e-con-full e-flex e-con e-child\" data-id=\"5a5846ea\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-181afcf2 elementor-widget elementor-widget-image\" data-id=\"181afcf2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1920\" height=\"2560\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-scaled.jpg\" class=\"attachment-full size-full wp-image-15584\" alt=\"A woman holding a smartphone in one hand and a stethoscope in the other. She wears medical gloves and appears to be in a hospital setting. Regulatory Medical Device Consultancy.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-scaled.jpg 1920w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-225x300.jpg 225w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-768x1024.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-1152x1536.jpg 1152w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-1536x2048.jpg 1536w\" sizes=\"(max-width: 1920px) 100vw, 1920px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6b5f0bb6 e-con-full e-flex e-con e-child\" data-id=\"6b5f0bb6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-29e2ee49 elementor-widget elementor-widget-heading\" data-id=\"29e2ee49\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Saia do Modo Emerg\u00eancia e Mostre um Plano Estruturado para a FDA<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-260a696a elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"260a696a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Problemas de conformidade com a FDA s\u00e3o estressantes \u2014 mas tamb\u00e9m s\u00e3o uma oportunidade para estabilizar o sistema da qualidade e recuperar a confian\u00e7a externa. Ajudamos a interpretar os achados da FDA, desenhar e documentar remedia\u00e7\u00e3o e CAPA e apoiar suas respostas, para que voc\u00ea mostre \u00e0 FDA e a clientes cr\u00edticos um caminho cr\u00edvel e controlado de volta \u00e0 conformidade.\"}]\" data-inline-monday=\"true\">Los problemas de conformidad con la FDA son estresantes, pero tambi\u00e9n son una oportunidad para estabilizar el sistema de calidad y recuperar la confianza externa. Te ayudamos a interpretar los resultados de la FDA, a dise\u00f1ar y documentar correcciones y CAPA, y a gestionar sus respuestas, para que muestres a la FDA y a los clientes cr\u00edticos un camino cr\u00edtico y controlado de vuelta a la conformidad. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1b54f06a elementor-align-left borda-piscando elementor-widget elementor-widget-button\" data-id=\"1b54f06a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-pulse\" href=\"#cta\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-envelope\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 64H48C21.49 64 0 85.49 0 112v288c0 26.51 21.49 48 48 48h416c26.51 0 48-21.49 48-48V112c0-26.51-21.49-48-48-48zm0 48v40.805c-22.422 18.259-58.168 46.651-134.587 106.49-16.841 13.247-50.201 45.072-73.413 44.701-23.208.375-56.579-31.459-73.413-44.701C106.18 199.465 70.425 171.067 48 152.805V112h416zM48 400V214.398c22.914 18.251 55.409 43.862 104.938 82.646 21.857 17.205 60.134 55.186 103.062 54.955 42.717.231 80.509-37.199 103.053-54.947 49.528-38.783 82.032-64.401 104.947-82.653V400H48z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Estabilizar mi situaci\u00f3n con la FDA<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6ee277bc e-flex e-con-boxed e-con e-parent\" data-id=\"6ee277bc\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-f593d12 e-con-full e-flex e-con e-child\" data-id=\"f593d12\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2d2815bd elementor-align-center elementor-widget elementor-widget-lottie\" data-id=\"2d2815bd\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;source_json&quot;:{&quot;url&quot;:&quot;https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2025\\\/10\\\/Contact-us.json&quot;,&quot;id&quot;:16710,&quot;size&quot;:&quot;&quot;,&quot;alt&quot;:&quot;&quot;,&quot;source&quot;:&quot;library&quot;},&quot;loop&quot;:&quot;yes&quot;,&quot;source&quot;:&quot;media_file&quot;,&quot;caption_source&quot;:&quot;none&quot;,&quot;link_to&quot;:&quot;none&quot;,&quot;trigger&quot;:&quot;arriving_to_viewport&quot;,&quot;viewport&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:0,&quot;end&quot;:100}},&quot;play_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:1,&quot;sizes&quot;:[]},&quot;start_point&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;end_point&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:100,&quot;sizes&quot;:[]},&quot;renderer&quot;:&quot;svg&quot;}\" data-widget_type=\"lottie.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"e-lottie__container\"><div class=\"e-lottie__animation\"><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-27ae0e e-con-full e-flex e-con e-child\" data-id=\"27ae0e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2a2ad6d elementor-widget elementor-widget-heading\" data-id=\"2a2ad6d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Fale conosco<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6db7c421 elementor-widget elementor-widget-heading\" data-id=\"6db7c421\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">\u00a1N\u00f3s adorar\u00edamos falar com voc\u00ea! Ponte en contacto con Sobel rellenando el siguiente formulario.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-36f9f279 elementor-widget__width-initial elementor-button-align-stretch elementor-widget elementor-widget-form\" data-id=\"36f9f279\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;step_next_label&quot;:&quot;Siguiente&quot;,&quot;step_previous_label&quot;:&quot;Anterior&quot;,&quot;button_width&quot;:&quot;100&quot;,&quot;step_type&quot;:&quot;number_text&quot;,&quot;step_icon_shape&quot;:&quot;circle&quot;}\" data-widget_type=\"form.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<form class=\"elementor-form\" method=\"post\" id=\"form_lp_br_fda_compliance_issues_pt\" name=\"Formulario de contacto br_fda_compliance_issues_pt\" aria-label=\"Formulario de contacto br_fda_compliance_issues_pt\">\n\t\t\t<input type=\"hidden\" name=\"post_id\" value=\"23423\"\/>\n\t\t\t<input type=\"hidden\" name=\"form_id\" value=\"36f9f279\"\/>\n\t\t\t<input type=\"hidden\" name=\"referer_title\" value=\"Sobel\" \/>\n\n\t\t\t\n\t\t\t<div class=\"elementor-form-fields-wrapper elementor-labels-above\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-first_name elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-first_name\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tNombre completo\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[first_name]\" id=\"form-field-first_name\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Digite aqu\u00ed\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-email elementor-field-group elementor-column elementor-field-group-email elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-email\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tCorreo electr\u00f3nico\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"email\" name=\"form_fields[email]\" id=\"form-field-email\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Digite aqu\u00ed\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-tel elementor-field-group elementor-column elementor-field-group-phone elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-phone\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tTel\u00e9fono\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t<input size=\"1\" type=\"tel\" name=\"form_fields[phone]\" id=\"form-field-phone\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Digite aqu\u00ed\" required=\"required\" pattern=\"[0-9()#&amp;+*-=.]+\" title=\"Solo se aceptan n\u00fameros y caracteres de tel\u00e9fono (#,-,*,etc).\">\n\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-company elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-company\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tEmpresa\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[company]\" id=\"form-field-company\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Digite aqu\u00ed\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-textarea elementor-field-group elementor-column elementor-field-group-message elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-message\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tMensaje\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t<textarea class=\"elementor-field-textual elementor-field  elementor-size-sm\" name=\"form_fields[message]\" id=\"form-field-message\" rows=\"4\" placeholder=\"Digite aqu\u00ed\"><\/textarea>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-acceptance elementor-field-group elementor-column elementor-field-group-privacyagreed elementor-col-100 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t<div class=\"elementor-field-subgroup\">\n\t\t\t<span class=\"elementor-field-option\">\n\t\t\t\t<input type=\"checkbox\" name=\"form_fields[privacyagreed]\" id=\"form-field-privacyagreed\" class=\"elementor-field elementor-size-sm  elementor-acceptance-field\" required=\"required\">\n\t\t\t\t<label for=\"form-field-privacyagreed\">&nbsp;&nbsp;  Estoy de acuerdo con la declaraci\u00f3n de privacidad de los datos y con los t\u00e9rminos y condiciones publicados en este sitio.<\/label>\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-acceptance elementor-field-group elementor-column elementor-field-group-newslettercheck elementor-col-100\">\n\t\t\t\t\t\t\t<div class=\"elementor-field-subgroup\">\n\t\t\t<span class=\"elementor-field-option\">\n\t\t\t\t<input type=\"checkbox\" name=\"form_fields[newslettercheck]\" id=\"form-field-newslettercheck\" class=\"elementor-field elementor-size-sm  elementor-acceptance-field\">\n\t\t\t\t<label for=\"form-field-newslettercheck\">&nbsp;  &amp;nbspConcuerda recibir boletines informativos quinquenales con actualizaciones sobre el mercado regulatorio global.<\/label>\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_source elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_source]\" id=\"form-field-utm_source\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_campaign elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_campaign]\" id=\"form-field-utm_campaign\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_adgroupname elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_adgroupname]\" id=\"form-field-utm_adgroupname\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_term elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_term]\" id=\"form-field-utm_term\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-gclid elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[gclid]\" id=\"form-field-gclid\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_content elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_content]\" id=\"form-field-utm_content\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_device elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_device]\" id=\"form-field-utm_device\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-group elementor-column elementor-field-type-submit elementor-col-100 e-form__buttons\">\n\t\t\t\t\t<button class=\"elementor-button elementor-size-sm\" type=\"submit\" id=\"btn_br_fda_compliance_issues_pt\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Enviar<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/button>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/form>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4f3d8cd1 elementor-widget elementor-widget-html\" data-id=\"4f3d8cd1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<link data-minify=\"1\" rel=\"stylesheet\" href=\"https:\/\/ciparoni.com\/wp-content\/cache\/background-css\/1\/ciparoni.com\/wp-content\/cache\/min\/1\/ajax\/libs\/intl-tel-input\/17.0.8\/css\/intlTelInput.css?ver=1760368402&amp;wpr_t=1760357602\">\r\n\r\n<script data-minify=\"1\" src=\"https:\/\/ciparoni.com\/wp-content\/cache\/min\/1\/ajax\/libs\/intl-tel-input\/17.0.8\/js\/intlTelInput.min.js?ver=1760368402\"><\/script>\r\n\r\n<script data-minify=\"1\" src=\"https:\/\/ciparoni.com\/wp-content\/cache\/min\/1\/ajax\/libs\/jquery\/3.7.1\/jquery.min.js?ver=1760368402\"><\/script>\r\n\r\n<script>\r\n    const phoneInputField = document.querySelectorAll('input[type=\"tel\"]');\r\n    const btForm = document.querySelectorAll('.elementor-button[type=\"submit\"]');\r\n    let telefones = [];\r\n\r\n    for (i = 0; i < phoneInputField.length; i++){\r\n        var phone_number = window.intlTelInput(phoneInputField[i], {\r\n        separateDialCode: true,\r\n        preferredCountries:[\"br\",\"us\", \"de\", \"fr\" ],\r\n        hiddenInput: \"full\",\r\n        utilsScript: \"\/\/cdnjs.cloudflare.com\/ajax\/libs\/intl-tel-input\/17.0.8\/js\/utils.js\"\r\n        });\r\n\r\n        telefones[i] = phone_number;\r\n    }\r\n    $(phoneInputField).each(function(i) {\r\n        $(\"form\").submit(function() {\r\n            var full_number = telefones[i].getNumber(intlTelInputUtils.numberFormat.E164);\r\n            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elementor-element-39c7b16e elementor-widget elementor-widget-theme-site-logo elementor-widget-image\" data-id=\"39c7b16e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-site-logo.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"741\" height=\"290\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.webp\" class=\"attachment-full size-full wp-image-8426\" alt=\"Logo Sobel White\" \/>\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d1b7fcb elementor-widget elementor-widget-heading\" data-id=\"d1b7fcb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/sobelconsult.com\/es\/declaracion-de-privacidad-us\/\" target=\"_blank\">Pol\u00edtica de privacidad<\/a><\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Fale com a Sobel Estados Unidos - FDA - Conformidad y Sistema de Calidad Problemas de Conformidad FDA - Investigaci\u00f3n y Soluci\u00f3n Traducimos lo que dice la FDA, conectamos los resultados a las acciones del sistema de calidad, dise\u00f1amos y documentamos el plan de remediaci\u00f3n y apoiamos sus respuestas - para salir del modo \u00abapagar [&hellip;]<\/p>\n","protected":false},"author":16,"featured_media":0,"parent":15866,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_canvas","meta":{"_angie_page":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-23423","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site 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