{"id":34943,"date":"2026-05-11T09:28:35","date_gmt":"2026-05-11T12:28:35","guid":{"rendered":"https:\/\/sobelconsult.com\/materiais\/us-510k-se-rationale\/"},"modified":"2026-05-28T16:35:53","modified_gmt":"2026-05-28T19:35:53","slug":"us-510k","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/pt-br\/lp\/medical-devices\/us-510k\/","title":{"rendered":"LP | Dispositivos m\u00e9dicos | US 510(k)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"34943\" class=\"elementor elementor-34943 elementor-34916\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-17e8886 e-con-full e-flex e-con e-parent\" data-id=\"17e8886\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-59a8218 e-flex e-con-boxed e-con e-child\" data-id=\"59a8218\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-97046ca elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"97046ca\" 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-BlueMain.webp\" class=\"attachment-full size-full wp-image-4516\" alt=\"Logo Sobel Blue\" \/>\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-c8b2150 elementor-align-left borda-piscando elementor-hidden-tablet elementor-hidden-mobile elementor-mobile-align-left elementor-widget elementor-widget-button\" data-id=\"c8b2150\" 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\t\t\t<span class=\"elementor-button-text\">Fale 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-ad33bd2 e-flex e-con-boxed e-con e-child\" data-id=\"ad33bd2\" 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-569e7d2 e-con-full e-flex e-con e-child\" data-id=\"569e7d2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-43b191d elementor-widget elementor-widget-heading\" data-id=\"43b191d\" 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\">Suporte \u00e0 prontid\u00e3o de envio de 510(k)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5b78965 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"5b78965\" 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\">Evite o <span class=\"hero-blue\">retrabalho<\/span> dispendioso <span class=\"hero-blue\">do 510(k)<\/span><br \/>antes de voc\u00ea enviar<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-da6b05e elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"da6b05e\" 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>Para empresas de dispositivos m\u00e9dicos que est\u00e3o preparando a documenta\u00e7\u00e3o 510(k) da FDA, estrat\u00e9gia de predicados, equival\u00eancia substancial ou entrada no mercado dos EUA.<\/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-2ff170b elementor-widget-mobile__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"2ff170b\" 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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-chevron-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Identificar lacunas na documenta\u00e7\u00e3o antes da an\u00e1lise da FDA<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-chevron-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Revisar o predicado e a estrat\u00e9gia de equival\u00eancia substancial<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-chevron-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Alinhe os testes, a rotulagem, as alega\u00e7\u00f5es e o uso pretendido<\/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-b3a3bb4 elementor-align-left borda-piscando elementor-mobile-align-left elementor-widget elementor-widget-button\" data-id=\"b3a3bb4\" 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\t\t\t<span class=\"elementor-button-text\">Verificar minha prontid\u00e3o para 510(k)<\/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-f0814d1 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"f0814d1\" 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>Criado para empresas com um dispositivo m\u00e9dico definido, documenta\u00e7\u00e3o em andamento ou uma meta clara de entrada no mercado dos EUA.<\/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-716cccf e-transform e-flex e-con-boxed e-con e-parent\" data-id=\"716cccf\" 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\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-5529cc8 e-con-full e-flex e-con e-child\" data-id=\"5529cc8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5b66c70 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"5b66c70\" 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>Confiado por equipes de mercados regulamentados<br><\/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 class=\"elementor-element elementor-element-5ae4456 elementor-widget elementor-widget-image-carousel\" data-id=\"5ae4456\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;slides_to_show&quot;:&quot;5&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 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-4-e1785701259234-rrbv89ia8gdxq0r54ih9brlgjfrzbldlpcap9i91vg.webp\" alt=\"Hypera Pharma logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"2 de 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-5-e1785701234356-rrbv7m0bhlhrnrp9xqbl3fixoszsz5sba3zk9l7w70.webp\" alt=\"CMOS Drake\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"3 de 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-6-e1785701205313-rrbv6uqzzeggb2svcwjel4ekgmq5rxs3id2hckcb7g.webp\" alt=\"Pasteur logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"4 de 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-7-e1785701176338-rrbv63hoh7f4ydwgs2r82ta78ggikprvqm5efjgq7w.webp\" alt=\"Ache logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"5 de 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-8-e1785701148522-rrbv5d675uf3xayp1rdo4zxalo28l6veazvszsjr24.webp\" alt=\"Teuto logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"6 de 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-9-e1785701119944-rrbv4lwvnndskm2agxlhmosxdhsldyv6j8yq2ro62k.webp\" alt=\"ADV Farma logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"7 de 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-10-e1785701097906-rrbv418fhalhh6wbtonp3u0sb0mioml34em1ioitvg.webp\" alt=\"SIN logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"8 de 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-11-e1785701066264-rrbv383flfhlha2nju29gjdhw2m520deoedzn3q18c.webp\" alt=\"Supera Farma logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"9 de 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-12-e1785701037693-rrbv2gu438ga4l68z0a2y894nwchusd6wngwq2ug8s.webp\" alt=\"Avenca logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"10 de 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-13-e1785701007365-rrbv1omye7dogab7jo39vfdauc7hfv98srwcbs09fg.webp\" alt=\"Dentsply Sirona logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"11 de 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-14-e1785700969629-rrbv0ox36i0s73r3c8ng8ods9p3jbdbfzv3w39h7zw.webp\" alt=\"Fresenius Kabi logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"12 de 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-1-e1785700931897-rrbuzp77ysnvxx6z4t7mlxe9p1zl6vdn6ybfuqy6kc.webp\" alt=\"B Braun logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"13 de 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-2-e1785700906155-rrbuz1p97xrpvo53y11ydlbquf7eufscrq0autx0vw.webp\" alt=\"Surya Brasil logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"14 de 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-3-e1785700805623-rrbuwerk1o5rb1z0ce0mvra6ui7c90bgqo49dvtscc.webp\" alt=\"Baruel 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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-56a2afd e-flex e-con-boxed e-con e-parent\" data-id=\"56a2afd\" 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-34425b4 e-con-full e-flex e-con e-child\" data-id=\"34425b4\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-eec538f e-con-full e-flex e-con e-child\" data-id=\"eec538f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-53afd88 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"53afd88\" 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\">Esse suporte 510(k) \u00e9 adequado para sua empresa?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fc8e713 elementor-widget elementor-widget-text-editor\" data-id=\"fc8e713\" 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>Esse servi\u00e7o foi projetado para equipes que preparam um dispositivo m\u00e9dico real para an\u00e1lise da FDA, e n\u00e3o para ideias iniciais, cursos ou pesquisas gerais.<\/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-852bee3 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"852bee3\" 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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 136.967-111.033 248-248 248S8 392.967 8 256 119.033 8 256 8s248 111.033 248 248zM227.314 387.314l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.249-16.379-6.249-22.628 0L216 308.118l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.249 16.379 6.249 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Voc\u00ea tem um dispositivo m\u00e9dico ou prot\u00f3tipo definido<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 136.967-111.033 248-248 248S8 392.967 8 256 119.033 8 256 8s248 111.033 248 248zM227.314 387.314l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.249-16.379-6.249-22.628 0L216 308.118l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.249 16.379 6.249 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Voc\u00ea est\u00e1 se preparando para o envio \u00e0 FDA dos EUA<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 136.967-111.033 248-248 248S8 392.967 8 256 119.033 8 256 8s248 111.033 248 248zM227.314 387.314l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.249-16.379-6.249-22.628 0L216 308.118l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.249 16.379 6.249 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Voc\u00ea precisa confirmar seu caminho 510(k)<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 136.967-111.033 248-248 248S8 392.967 8 256 119.033 8 256 8s248 111.033 248 248zM227.314 387.314l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.249-16.379-6.249-22.628 0L216 308.118l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.249 16.379 6.249 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Sua documenta\u00e7\u00e3o pode precisar de revis\u00e3o regulamentar<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 136.967-111.033 248-248 248S8 392.967 8 256 119.033 8 256 8s248 111.033 248 248zM227.314 387.314l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.249-16.379-6.249-22.628 0L216 308.118l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.249 16.379 6.249 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Voc\u00ea precisa de clareza antes de investir mais tempo ou or\u00e7amento<\/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-27cfaab elementor-widget elementor-widget-text-editor\" data-id=\"27cfaab\" 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\":\"If route, predicate, evidence or eSTAR structure are still uncertain, Sobel can help organize the next step.\"}]\" data-inline-monday=\"true\">Se a rota, o predicado, a evid\u00eancia ou a estrutura do eSTAR ainda estiverem incertos, <strong>o Sobel pode ajudar a organizar a pr\u00f3xima etapa.<\/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-feea52c e-con-full e-flex e-con e-child\" data-id=\"feea52c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e4dee7e elementor-widget elementor-widget-image\" data-id=\"e4dee7e\" 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=\"1000\" height=\"667\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/04\/biological-evaluation-of-medical-devices.jpg\" class=\"attachment-full size-full wp-image-34167\" alt=\"Women&apos;s hands pointing to information in documents in a business setting.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/04\/biological-evaluation-of-medical-devices.jpg 1000w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/04\/biological-evaluation-of-medical-devices-300x200.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/04\/biological-evaluation-of-medical-devices-768x512.jpg 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/>\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\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6aeb7cf e-con-full e-flex e-con e-parent\" data-id=\"6aeb7cf\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-73ed7a9 e-con-full e-flex e-con e-child\" data-id=\"73ed7a9\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3b70d56 elementor-widget elementor-widget-heading\" data-id=\"3b70d56\" 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\">A maioria dos atrasos do 510(k) come\u00e7a antes do envio\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-355f372 elementor-widget elementor-widget-text-editor\" data-id=\"355f372\" 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>Uma estrat\u00e9gia de predicado fraca, uma documenta\u00e7\u00e3o pouco clara ou reivindica\u00e7\u00f5es inconsistentes podem gerar d\u00favidas, retrabalho e atrasos por parte da FDA.<\/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-ad9f89b e-flex e-con-boxed e-con e-child\" data-id=\"ad9f89b\" 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-daee997 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"daee997\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeInLeft&quot;,&quot;animation_delay&quot;:0}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-695f0f9 elementor-widget elementor-widget-heading\" data-id=\"695f0f9\" 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\">Problemas comuns<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-88126e0 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"88126e0\" 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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-window-close\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 32H48C21.5 32 0 53.5 0 80v352c0 26.5 21.5 48 48 48h416c26.5 0 48-21.5 48-48V80c0-26.5-21.5-48-48-48zm0 394c0 3.3-2.7 6-6 6H54c-3.3 0-6-2.7-6-6V86c0-3.3 2.7-6 6-6h404c3.3 0 6 2.7 6 6v340zM356.5 194.6L295.1 256l61.4 61.4c4.6 4.6 4.6 12.1 0 16.8l-22.3 22.3c-4.6 4.6-12.1 4.6-16.8 0L256 295.1l-61.4 61.4c-4.6 4.6-12.1 4.6-16.8 0l-22.3-22.3c-4.6-4.6-4.6-12.1 0-16.8l61.4-61.4-61.4-61.4c-4.6-4.6-4.6-12.1 0-16.8l22.3-22.3c4.6-4.6 12.1-4.6 16.8 0l61.4 61.4 61.4-61.4c4.6-4.6 12.1-4.6 16.8 0l22.3 22.3c4.7 4.6 4.7 12.1 0 16.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">A compara\u00e7\u00e3o de predicados est\u00e1 incompleta<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-window-close\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 32H48C21.5 32 0 53.5 0 80v352c0 26.5 21.5 48 48 48h416c26.5 0 48-21.5 48-48V80c0-26.5-21.5-48-48-48zm0 394c0 3.3-2.7 6-6 6H54c-3.3 0-6-2.7-6-6V86c0-3.3 2.7-6 6-6h404c3.3 0 6 2.7 6 6v340zM356.5 194.6L295.1 256l61.4 61.4c4.6 4.6 4.6 12.1 0 16.8l-22.3 22.3c-4.6 4.6-12.1 4.6-16.8 0L256 295.1l-61.4 61.4c-4.6 4.6-12.1 4.6-16.8 0l-22.3-22.3c-4.6-4.6-4.6-12.1 0-16.8l61.4-61.4-61.4-61.4c-4.6-4.6-4.6-12.1 0-16.8l22.3-22.3c4.6-4.6 12.1-4.6 16.8 0l61.4 61.4 61.4-61.4c4.6-4.6 12.1-4.6 16.8 0l22.3 22.3c4.7 4.6 4.7 12.1 0 16.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">O uso pretendido n\u00e3o \u00e9 claro ou \u00e9 inconsistente<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-window-close\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 32H48C21.5 32 0 53.5 0 80v352c0 26.5 21.5 48 48 48h416c26.5 0 48-21.5 48-48V80c0-26.5-21.5-48-48-48zm0 394c0 3.3-2.7 6-6 6H54c-3.3 0-6-2.7-6-6V86c0-3.3 2.7-6 6-6h404c3.3 0 6 2.7 6 6v340zM356.5 194.6L295.1 256l61.4 61.4c4.6 4.6 4.6 12.1 0 16.8l-22.3 22.3c-4.6 4.6-12.1 4.6-16.8 0L256 295.1l-61.4 61.4c-4.6 4.6-12.1 4.6-16.8 0l-22.3-22.3c-4.6-4.6-4.6-12.1 0-16.8l61.4-61.4-61.4-61.4c-4.6-4.6-4.6-12.1 0-16.8l22.3-22.3c4.6-4.6 12.1-4.6 16.8 0l61.4 61.4 61.4-61.4c4.6-4.6 12.1-4.6 16.8 0l22.3 22.3c4.7 4.6 4.7 12.1 0 16.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">As evid\u00eancias dos testes n\u00e3o suportam as alega\u00e7\u00f5es<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-window-close\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 32H48C21.5 32 0 53.5 0 80v352c0 26.5 21.5 48 48 48h416c26.5 0 48-21.5 48-48V80c0-26.5-21.5-48-48-48zm0 394c0 3.3-2.7 6-6 6H54c-3.3 0-6-2.7-6-6V86c0-3.3 2.7-6 6-6h404c3.3 0 6 2.7 6 6v340zM356.5 194.6L295.1 256l61.4 61.4c4.6 4.6 4.6 12.1 0 16.8l-22.3 22.3c-4.6 4.6-12.1 4.6-16.8 0L256 295.1l-61.4 61.4c-4.6 4.6-12.1 4.6-16.8 0l-22.3-22.3c-4.6-4.6-4.6-12.1 0-16.8l61.4-61.4-61.4-61.4c-4.6-4.6-4.6-12.1 0-16.8l22.3-22.3c4.6-4.6 12.1-4.6 16.8 0l61.4 61.4 61.4-61.4c4.6-4.6 12.1-4.6 16.8 0l22.3 22.3c4.7 4.6 4.7 12.1 0 16.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">A rotulagem n\u00e3o corresponde \u00e0 estrat\u00e9gia de envio<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-window-close\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 32H48C21.5 32 0 53.5 0 80v352c0 26.5 21.5 48 48 48h416c26.5 0 48-21.5 48-48V80c0-26.5-21.5-48-48-48zm0 394c0 3.3-2.7 6-6 6H54c-3.3 0-6-2.7-6-6V86c0-3.3 2.7-6 6-6h404c3.3 0 6 2.7 6 6v340zM356.5 194.6L295.1 256l61.4 61.4c4.6 4.6 4.6 12.1 0 16.8l-22.3 22.3c-4.6 4.6-12.1 4.6-16.8 0L256 295.1l-61.4 61.4c-4.6 4.6-12.1 4.6-16.8 0l-22.3-22.3c-4.6-4.6-4.6-12.1 0-16.8l61.4-61.4-61.4-61.4c-4.6-4.6-4.6-12.1 0-16.8l22.3-22.3c4.6-4.6 12.1-4.6 16.8 0l61.4 61.4 61.4-61.4c4.6-4.6 12.1-4.6 16.8 0l22.3 22.3c4.7 4.6 4.7 12.1 0 16.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">As diferen\u00e7as tecnol\u00f3gicas n\u00e3o s\u00e3o explicadas<\/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<div class=\"elementor-element elementor-element-a61f065 elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-image\" data-id=\"a61f065\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;tada&quot;}\" 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=\"458\" height=\"458\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/attention-icon.webp\" class=\"attachment-large size-large wp-image-36047\" alt=\"attention icon\" \/>\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<div class=\"elementor-element elementor-element-27583e0 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"27583e0\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeInRight&quot;,&quot;animation_delay&quot;:0}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-da16916 elementor-widget elementor-widget-heading\" data-id=\"da16916\" 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\">O que isso pode causar<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-03d996b elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"03d996b\" 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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-square\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M400 480H48c-26.51 0-48-21.49-48-48V80c0-26.51 21.49-48 48-48h352c26.51 0 48 21.49 48 48v352c0 26.51-21.49 48-48 48zm-204.686-98.059l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.248-16.379-6.249-22.628 0L184 302.745l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.25 16.379 6.25 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Perguntas adicionais da FDA<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-square\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M400 480H48c-26.51 0-48-21.49-48-48V80c0-26.51 21.49-48 48-48h352c26.51 0 48 21.49 48 48v352c0 26.51-21.49 48-48 48zm-204.686-98.059l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.248-16.379-6.249-22.628 0L184 302.745l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.25 16.379 6.25 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Solicita\u00e7\u00f5es de esclarecimentos ou novas evid\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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-square\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M400 480H48c-26.51 0-48-21.49-48-48V80c0-26.51 21.49-48 48-48h352c26.51 0 48 21.49 48 48v352c0 26.51-21.49 48-48 48zm-204.686-98.059l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.248-16.379-6.249-22.628 0L184 302.745l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.25 16.379 6.25 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Atrasos no envio ou na libera\u00e7\u00e3o<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-square\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M400 480H48c-26.51 0-48-21.49-48-48V80c0-26.51 21.49-48 48-48h352c26.51 0 48 21.49 48 48v352c0 26.51-21.49 48-48 48zm-204.686-98.059l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.248-16.379-6.249-22.628 0L184 302.745l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.25 16.379 6.25 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Custos extras de regulamenta\u00e7\u00e3o, testes ou documenta\u00e7\u00e3o<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-square\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M400 480H48c-26.51 0-48-21.49-48-48V80c0-26.51 21.49-48 48-48h352c26.51 0 48 21.49 48 48v352c0 26.51-21.49 48-48 48zm-204.686-98.059l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.248-16.379-6.249-22.628 0L184 302.745l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.25 16.379 6.25 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Incerteza interna antes do envio<\/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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fc117b4 e-con-full e-flex e-con e-parent\" data-id=\"fc117b4\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-04f82fc e-flex e-con-boxed e-con e-child\" data-id=\"04f82fc\" 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-a20ea2b e-con-full e-flex e-con e-child\" data-id=\"a20ea2b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-10a050a elementor-widget elementor-widget-heading\" data-id=\"10a050a\" 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\">A SOLU\u00c7\u00c3O<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bf93512 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"bf93512\" 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\">Transforme informa\u00e7\u00f5es dispersas sobre dispositivos em uma estrat\u00e9gia 510(k) clara\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-06e4964 elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"06e4964\" 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>A Sobel ajuda a organizar o caminho regulat\u00f3rio, as lacunas na documenta\u00e7\u00e3o e a l\u00f3gica de envio antes de voc\u00ea seguir em frente.<\/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-1b0a284 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"1b0a284\" 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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-chevron-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Revise as informa\u00e7\u00f5es do dispositivo e o uso pretendido<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-chevron-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Avaliar a l\u00f3gica de equival\u00eancia substancial e de predicados<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-chevron-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Identificar lacunas de documenta\u00e7\u00e3o, testes e rotulagem<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-chevron-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Definir as pr\u00f3ximas etapas pr\u00e1ticas antes do envio<\/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-67d7bb1 elementor-align-left borda-piscando elementor-mobile-align-left elementor-widget elementor-widget-button\" data-id=\"67d7bb1\" 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\t\t\t<span class=\"elementor-button-text\">Agende uma avalia\u00e7\u00e3o gratuita<\/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<div class=\"elementor-element elementor-element-43c0194 e-con-full e-flex e-con e-child\" data-id=\"43c0194\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c62bed2 elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-widget elementor-widget-image\" data-id=\"c62bed2\" 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 loading=\"lazy\" decoding=\"async\" width=\"951\" height=\"960\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/FDA-registration.jpg\" class=\"attachment-full size-full wp-image-36098\" alt=\"FDA registration of Medical Devices or Cosmetics\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/FDA-registration.jpg 951w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/FDA-registration-297x300.jpg 297w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/FDA-registration-150x150.jpg 150w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/FDA-registration-768x775.jpg 768w\" sizes=\"(max-width: 951px) 100vw, 951px\" \/>\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\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-79f04d4 e-con-full e-flex e-con e-parent\" data-id=\"79f04d4\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-a4daf92 e-con-full e-flex e-con e-child\" data-id=\"a4daf92\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ce13233 elementor-widget elementor-widget-heading\" data-id=\"ce13233\" 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\">O que voc\u00ea recebe<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a4cc7cf elementor-widget elementor-widget-text-editor\" data-id=\"a4cc7cf\" 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\":\"Your deliverables are designed to make the 510(k) logic easier to review, organize and defend internally.\"}]\" data-inline-monday=\"true\">Seus produtos s\u00e3o projetados para facilitar a revis\u00e3o, a organiza\u00e7\u00e3o e a defesa da l\u00f3gica 510(k) internamente.<\/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-f09375c e-flex e-con-boxed e-con e-child\" data-id=\"f09375c\" 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-1777996 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"1777996\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&quot;,&quot;animation_delay&quot;:10}\">\n\t\t<div class=\"elementor-element elementor-element-9cd140f e-con-full e-flex e-con e-child\" data-id=\"9cd140f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-152fa03 elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"152fa03\" 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 loading=\"lazy\" decoding=\"async\" width=\"458\" height=\"458\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/One-Navy-Blue.webp\" class=\"attachment-large size-large wp-image-36071\" alt=\"One - Navy Blue\" \/>\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<div class=\"elementor-element elementor-element-ce0e2fe e-con-full e-flex e-con e-child\" data-id=\"ce0e2fe\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ead82ef elementor-widget elementor-widget-heading\" data-id=\"ead82ef\" 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\">Revis\u00e3o do produto e da rota<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b8173ce elementor-widget elementor-widget-text-editor\" data-id=\"b8173ce\" 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=\"[{\"attributes\":{\"bold\":true},\"insert\":\"Clarify the path before building the file.\"}]\" data-inline-monday=\"true\">Esclare\u00e7a o caminho 510(k), o posicionamento do dispositivo, o uso pretendido e a rota regulat\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\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-18cf318 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"18cf318\" 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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Avalia\u00e7\u00e3o do predicado do candidato<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Rota 510(k) recomendada<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Justificativa para o caminho selecionado<\/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-4e64fe5 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"4e64fe5\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&quot;,&quot;animation_delay&quot;:5}\">\n\t\t<div class=\"elementor-element elementor-element-2b5d4f4 e-con-full e-flex e-con e-child\" data-id=\"2b5d4f4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-b63522b e-con-full e-flex e-con e-child\" data-id=\"b63522b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a555fbd elementor-widget elementor-widget-heading\" data-id=\"a555fbd\" 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\">Verifica\u00e7\u00e3o de predicados e reivindica\u00e7\u00f5es<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2b8ad58 elementor-widget elementor-widget-text-editor\" data-id=\"2b8ad58\" 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>Analise a l\u00f3gica de predicados, a l\u00f3gica de equival\u00eancia substancial, as reivindica\u00e7\u00f5es e a consist\u00eancia da rotulagem.<\/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 class=\"elementor-element elementor-element-6f6678a elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"6f6678a\" 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 loading=\"lazy\" decoding=\"async\" width=\"458\" height=\"458\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/Two-Navy-Blue.webp\" class=\"attachment-large size-large wp-image-36065\" alt=\"Two - Navy Blue\" \/>\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 class=\"elementor-element elementor-element-1357691 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"1357691\" 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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Compara\u00e7\u00e3o de uso pretendido e indica\u00e7\u00f5es<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Compara\u00e7\u00e3o de caracter\u00edsticas tecnol\u00f3gicas<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\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 de r\u00f3tulos e reivindica\u00e7\u00f5es<\/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-50984ae e-flex e-con-boxed e-con e-child\" data-id=\"50984ae\" 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-aadd52b e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"aadd52b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&quot;,&quot;animation_delay&quot;:10}\">\n\t\t<div class=\"elementor-element elementor-element-c912a51 e-con-full e-flex e-con e-child\" data-id=\"c912a51\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-34d87ee e-con-full e-flex e-con e-child\" data-id=\"34d87ee\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ae01847 elementor-widget elementor-widget-heading\" data-id=\"ae01847\" 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\">Revis\u00e3o da lacuna de evid\u00eancias<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d37b5e0 elementor-widget elementor-widget-text-editor\" data-id=\"d37b5e0\" 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 contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"attributes\":{\"bold\":true},\"insert\":\"Show how your data supports the SE rationale.\"}]\" data-inline-monday=\"true\">Identifique a documenta\u00e7\u00e3o ausente, fraca ou inconsistente antes que surjam perguntas da FDA.<\/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 class=\"elementor-element elementor-element-a066eab elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"a066eab\" 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 loading=\"lazy\" decoding=\"async\" width=\"458\" height=\"458\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/Three-Navy-Blue.webp\" class=\"attachment-large size-large wp-image-36059\" alt=\"Three - Navy Blue\" \/>\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 class=\"elementor-element elementor-element-ed5a4d7 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"ed5a4d7\" 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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Evid\u00eancias mapeadas para afirma\u00e7\u00f5es e perguntas de SE<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Padr\u00f5es aplic\u00e1veis e expectativas de teste<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Identifica\u00e7\u00e3o de lacunas antes do envio<\/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-6d201ae e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"6d201ae\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&quot;,&quot;animation_delay&quot;:5}\">\n\t\t<div class=\"elementor-element elementor-element-83abb40 e-con-full e-flex e-con e-child\" data-id=\"83abb40\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-e370e67 e-con-full e-flex e-con e-child\" data-id=\"e370e67\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b894afc elementor-widget elementor-widget-heading\" data-id=\"b894afc\" 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\">Prepara\u00e7\u00e3o do pacote de envio<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6fbbdda elementor-widget elementor-widget-text-editor\" data-id=\"6fbbdda\" 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>Receba as pr\u00f3ximas etapas claras para concluir, corrigir ou fortalecer sua prepara\u00e7\u00e3o para o 510(k).<\/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 class=\"elementor-element elementor-element-63441aa elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"63441aa\" 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 loading=\"lazy\" decoding=\"async\" width=\"458\" height=\"458\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/Four-Navy-Blue.webp\" class=\"attachment-large size-large wp-image-36053\" alt=\"Four - Navy Blue\" \/>\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 class=\"elementor-element elementor-element-0a93731 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"0a93731\" 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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Conte\u00fado organizado por se\u00e7\u00f5es eSTAR<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\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 verifica\u00e7\u00e3o de aceita\u00e7\u00e3o antes do voo<\/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<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Pacote de entrega para seu propriet\u00e1rio regulador<\/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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6aee21a e-con-full e-flex e-con e-parent\" data-id=\"6aee21a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-7f64fe0 e-con-full e-flex e-con e-child\" data-id=\"7f64fe0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5fb4f96 elementor-widget elementor-widget-heading\" data-id=\"5fb4f96\" 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\">Prepara\u00e7\u00e3o 510(k) simples e estruturada<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a2dd157 elementor-widget elementor-widget-text-editor\" data-id=\"a2dd157\" 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\":\"A clear workflow helps your team reduce uncertainty before the submission is assembled.\"}]\" data-inline-monday=\"true\">Um fluxo de trabalho claro ajuda a sua equipe a reduzir as incertezas antes da montagem do envio.<\/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-4f95445 e-con-full process-timeline e-flex e-con e-child\" data-id=\"4f95445\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-8df169b e-con-full proc-item e-flex e-con e-child\" data-id=\"8df169b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-51c0f02 elementor-widget elementor-widget-heading\" data-id=\"51c0f02\" 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\">1<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f92da05 proc-icon elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"f92da05\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\" icon_cloud-upload_alt\"><\/i>\t\t\t<\/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 class=\"elementor-element elementor-element-0b8a733 proc-text elementor-widget elementor-widget-text-editor\" data-id=\"0b8a733\" 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>Voc\u00ea compartilha as informa\u00e7\u00f5es do seu dispositivo<\/strong><\/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-a25ed13 elementor-widget elementor-widget-text-editor\" data-id=\"a25ed13\" 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>Envie a documenta\u00e7\u00e3o dispon\u00edvel, o uso pretendido, as reivindica\u00e7\u00f5es, a rotulagem, os testes e os detalhes do produto<\/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-59afe58 e-con-full proc-item e-flex e-con e-child\" data-id=\"59afe58\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9fe9992 elementor-widget elementor-widget-heading\" data-id=\"9fe9992\" 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\">2<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4656f40 proc-icon elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"4656f40\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\" icon_folder-alt\"><\/i>\t\t\t<\/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 class=\"elementor-element elementor-element-0f0826c proc-text elementor-widget elementor-widget-text-editor\" data-id=\"0f0826c\" 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>Avaliamos sua posi\u00e7\u00e3o 510(k):<\/strong><\/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-5e02d78 elementor-widget elementor-widget-text-editor\" data-id=\"5e02d78\" 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>Analisamos seu caminho, a estrat\u00e9gia de predicados e a l\u00f3gica de equival\u00eancia substancial<\/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-060b507 e-con-full proc-item e-flex e-con e-child\" data-id=\"060b507\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9db19a8 elementor-widget elementor-widget-heading\" data-id=\"9db19a8\" 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\">3<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5ce77e6 proc-icon elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"5ce77e6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-check-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 48c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m140.204 130.267l-22.536-22.718c-4.667-4.705-12.265-4.736-16.97-.068L215.346 303.697l-59.792-60.277c-4.667-4.705-12.265-4.736-16.97-.069l-22.719 22.536c-4.705 4.667-4.736 12.265-.068 16.971l90.781 91.516c4.667 4.705 12.265 4.736 16.97.068l172.589-171.204c4.704-4.668 4.734-12.266.067-16.971z\"><\/path><\/svg>\t\t\t<\/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 class=\"elementor-element elementor-element-31d7528 proc-text elementor-widget elementor-widget-text-editor\" data-id=\"31d7528\" 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>Identificamos os principais riscos:<\/strong><\/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-dac9431 elementor-widget elementor-widget-text-editor\" data-id=\"dac9431\" 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>Identificamos lacunas na documenta\u00e7\u00e3o, nas evid\u00eancias, nos r\u00f3tulos ou nos testes que podem gerar questionamentos da FDA.<\/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-988a068 e-con-full proc-item e-flex e-con e-child\" data-id=\"988a068\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1671212 elementor-widget elementor-widget-heading\" data-id=\"1671212\" 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\">4<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-62811ad proc-icon elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"62811ad\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\" icon_pencil-edit\"><\/i>\t\t\t<\/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 class=\"elementor-element elementor-element-08aa6d8 proc-text elementor-widget elementor-widget-text-editor\" data-id=\"08aa6d8\" 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>Organizamos as pr\u00f3ximas etapas:<\/strong><\/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-e6516ef elementor-widget elementor-widget-text-editor\" data-id=\"e6516ef\" 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>Voc\u00ea recebe uma vis\u00e3o estruturada do que precisa ser corrigido, conclu\u00eddo ou esclarecido.<\/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-915fa81 e-con-full proc-item e-flex e-con e-child\" data-id=\"915fa81\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d3789f7 elementor-widget elementor-widget-heading\" data-id=\"d3789f7\" 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\">5<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-612baac proc-icon elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"612baac\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-clipboard-check\" viewBox=\"0 0 384 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M336 64h-80c0-35.3-28.7-64-64-64s-64 28.7-64 64H48C21.5 64 0 85.5 0 112v352c0 26.5 21.5 48 48 48h288c26.5 0 48-21.5 48-48V112c0-26.5-21.5-48-48-48zM192 40c13.3 0 24 10.7 24 24s-10.7 24-24 24-24-10.7-24-24 10.7-24 24-24zm121.2 231.8l-143 141.8c-4.7 4.7-12.3 4.6-17-.1l-82.6-83.3c-4.7-4.7-4.6-12.3.1-17L99.1 285c4.7-4.7 12.3-4.6 17 .1l46 46.4 106-105.2c4.7-4.7 12.3-4.6 17 .1l28.2 28.4c4.7 4.8 4.6 12.3-.1 17z\"><\/path><\/svg>\t\t\t<\/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 class=\"elementor-element elementor-element-cfdcb37 proc-text elementor-widget elementor-widget-text-editor\" data-id=\"cfdcb37\" 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>Voc\u00ea segue em frente com confian\u00e7a:<\/strong><\/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-97da40c elementor-widget elementor-widget-text-editor\" data-id=\"97da40c\" 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>Sua equipe recebe a documenta\u00e7\u00e3o, as anota\u00e7\u00f5es e a entrega necess\u00e1rias para prosseguir.<\/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>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d31e2ed e-flex e-con-boxed e-con e-parent\" data-id=\"d31e2ed\" 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-3e28b45 e-con-full e-flex e-con e-child\" data-id=\"3e28b45\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c7b4c25 elementor-widget elementor-widget-heading\" data-id=\"c7b4c25\" 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\">Por que as empresas escolhem a Sobel antes da apresenta\u00e7\u00e3o \u00e0 FDA\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-15070ae elementor-widget elementor-widget-text-editor\" data-id=\"15070ae\" 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\":\"Specialized 510(k) support built around predicate strategy, substantial equivalence and eSTAR readiness.\"}]\" data-inline-monday=\"true\">Suporte especializado para empresas que preparam a documenta\u00e7\u00e3o 510(k), a estrat\u00e9gia da FDA e a entrada no mercado dos EUA.<\/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-fb10006 e-con-full e-flex e-con e-child\" data-id=\"fb10006\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-e0c9bc1 e-con-full e-flex e-con e-child\" data-id=\"e0c9bc1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-5cb9e61 e-con-full e-flex e-con e-child\" data-id=\"5cb9e61\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dcc5884 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"dcc5884\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-clipboard-list\" viewBox=\"0 0 384 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M336 64h-80c0-35.3-28.7-64-64-64s-64 28.7-64 64H48C21.5 64 0 85.5 0 112v352c0 26.5 21.5 48 48 48h288c26.5 0 48-21.5 48-48V112c0-26.5-21.5-48-48-48zM96 424c-13.3 0-24-10.7-24-24s10.7-24 24-24 24 10.7 24 24-10.7 24-24 24zm0-96c-13.3 0-24-10.7-24-24s10.7-24 24-24 24 10.7 24 24-10.7 24-24 24zm0-96c-13.3 0-24-10.7-24-24s10.7-24 24-24 24 10.7 24 24-10.7 24-24 24zm96-192c13.3 0 24 10.7 24 24s-10.7 24-24 24-24-10.7-24-24 10.7-24 24-24zm128 368c0 4.4-3.6 8-8 8H168c-4.4 0-8-3.6-8-8v-16c0-4.4 3.6-8 8-8h144c4.4 0 8 3.6 8 8v16zm0-96c0 4.4-3.6 8-8 8H168c-4.4 0-8-3.6-8-8v-16c0-4.4 3.6-8 8-8h144c4.4 0 8 3.6 8 8v16zm0-96c0 4.4-3.6 8-8 8H168c-4.4 0-8-3.6-8-8v-16c0-4.4 3.6-8 8-8h144c4.4 0 8 3.6 8 8v16z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ed6b7f1 e-con-full e-flex e-con e-child\" data-id=\"ed6b7f1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dd3f8e9 elementor-widget elementor-widget-heading\" data-id=\"dd3f8e9\" 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\">Reduzir o retrabalho evit\u00e1vel<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d627da2 elementor-widget elementor-widget-text-editor\" data-id=\"d627da2\" 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>Ajudamos a identificar lacunas regulat\u00f3rias e de documenta\u00e7\u00e3o antes que elas se transformem em atrasos dispendiosos.<\/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<div class=\"elementor-element elementor-element-6dc484e e-con-full e-flex e-con e-child\" data-id=\"6dc484e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e2e538a elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"e2e538a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-globe-americas\" viewBox=\"0 0 496 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M248 8C111.03 8 0 119.03 0 256s111.03 248 248 248 248-111.03 248-248S384.97 8 248 8zm82.29 357.6c-3.9 3.88-7.99 7.95-11.31 11.28-2.99 3-5.1 6.7-6.17 10.71-1.51 5.66-2.73 11.38-4.77 16.87l-17.39 46.85c-13.76 3-28 4.69-42.65 4.69v-27.38c1.69-12.62-7.64-36.26-22.63-51.25-6-6-9.37-14.14-9.37-22.63v-32.01c0-11.64-6.27-22.34-16.46-27.97-14.37-7.95-34.81-19.06-48.81-26.11-11.48-5.78-22.1-13.14-31.65-21.75l-.8-.72a114.792 114.792 0 0 1-18.06-20.74c-9.38-13.77-24.66-36.42-34.59-51.14 20.47-45.5 57.36-82.04 103.2-101.89l24.01 12.01C203.48 89.74 216 82.01 216 70.11v-11.3c7.99-1.29 16.12-2.11 24.39-2.42l28.3 28.3c6.25 6.25 6.25 16.38 0 22.63L264 112l-10.34 10.34c-3.12 3.12-3.12 8.19 0 11.31l4.69 4.69c3.12 3.12 3.12 8.19 0 11.31l-8 8a8.008 8.008 0 0 1-5.66 2.34h-8.99c-2.08 0-4.08.81-5.58 2.27l-9.92 9.65a8.008 8.008 0 0 0-1.58 9.31l15.59 31.19c2.66 5.32-1.21 11.58-7.15 11.58h-5.64c-1.93 0-3.79-.7-5.24-1.96l-9.28-8.06a16.017 16.017 0 0 0-15.55-3.1l-31.17 10.39a11.95 11.95 0 0 0-8.17 11.34c0 4.53 2.56 8.66 6.61 10.69l11.08 5.54c9.41 4.71 19.79 7.16 30.31 7.16s22.59 27.29 32 32h66.75c8.49 0 16.62 3.37 22.63 9.37l13.69 13.69a30.503 30.503 0 0 1 8.93 21.57 46.536 46.536 0 0 1-13.72 32.98zM417 274.25c-5.79-1.45-10.84-5-14.15-9.97l-17.98-26.97a23.97 23.97 0 0 1 0-26.62l19.59-29.38c2.32-3.47 5.5-6.29 9.24-8.15l12.98-6.49C440.2 193.59 448 223.87 448 256c0 8.67-.74 17.16-1.82 25.54L417 274.25z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-24b5ec1 e-con-full e-flex e-con e-child\" data-id=\"24b5ec1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e314393 elementor-widget elementor-widget-heading\" data-id=\"e314393\" 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\">Suporte para empresas internacionais<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-146560a elementor-widget elementor-widget-text-editor\" data-id=\"146560a\" 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 translate test data, labeling, claims and technology differences into clear regulatory arguments.\"}]\" data-inline-monday=\"true\">Orientamos fabricantes estrangeiros que est\u00e3o se preparando para entrar no mercado de dispositivos m\u00e9dicos dos EUA.<\/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<div class=\"elementor-element elementor-element-fe354c0 e-con-full e-flex e-con e-child\" data-id=\"fe354c0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e56eda7 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"e56eda7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-clipboard-check\" viewBox=\"0 0 384 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M336 64h-80c0-35.3-28.7-64-64-64s-64 28.7-64 64H48C21.5 64 0 85.5 0 112v352c0 26.5 21.5 48 48 48h288c26.5 0 48-21.5 48-48V112c0-26.5-21.5-48-48-48zM192 40c13.3 0 24 10.7 24 24s-10.7 24-24 24-24-10.7-24-24 10.7-24 24-24zm121.2 231.8l-143 141.8c-4.7 4.7-12.3 4.6-17-.1l-82.6-83.3c-4.7-4.7-4.6-12.3.1-17L99.1 285c4.7-4.7 12.3-4.6 17 .1l46 46.4 106-105.2c4.7-4.7 12.3-4.6 17 .1l28.2 28.4c4.7 4.8 4.6 12.3-.1 17z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4f1dff0 e-con-full e-flex e-con e-child\" data-id=\"4f1dff0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a2810c5 elementor-widget elementor-widget-heading\" data-id=\"a2810c5\" 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\">Estrat\u00e9gia al\u00e9m da montagem de documentos<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a26c0fd elementor-widget elementor-widget-text-editor\" data-id=\"a26c0fd\" 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 structure content around the format, prompts and acceptance logic FDA expects.\"}]\" data-inline-monday=\"true\">Nossa an\u00e1lise conecta o uso pretendido, a l\u00f3gica de predicados, as evid\u00eancias, a rotulagem e a prontid\u00e3o de envio.<\/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<div class=\"elementor-element elementor-element-ecae8e2 e-con-full e-flex e-con e-child\" data-id=\"ecae8e2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-69c239b elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"69c239b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-route\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 320h-96c-17.6 0-32-14.4-32-32s14.4-32 32-32h96s96-107 96-160-43-96-96-96-96 43-96 96c0 25.5 22.2 63.4 45.3 96H320c-52.9 0-96 43.1-96 96s43.1 96 96 96h96c17.6 0 32 14.4 32 32s-14.4 32-32 32H185.5c-16 24.8-33.8 47.7-47.3 64H416c52.9 0 96-43.1 96-96s-43.1-96-96-96zm0-256c17.7 0 32 14.3 32 32s-14.3 32-32 32-32-14.3-32-32 14.3-32 32-32zM96 256c-53 0-96 43-96 96s96 160 96 160 96-107 96-160-43-96-96-96zm0 128c-17.7 0-32-14.3-32-32s14.3-32 32-32 32 14.3 32 32-14.3 32-32 32z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-31c11c8 e-con-full e-flex e-con e-child\" data-id=\"31c11c8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5628aad elementor-widget elementor-widget-heading\" data-id=\"5628aad\" 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\">Pr\u00f3ximas etapas regulat\u00f3rias claras<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8506f6c elementor-widget elementor-widget-text-editor\" data-id=\"8506f6c\" 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 help internal teams align before submission, reducing confusion and rework.\"}]\" data-inline-monday=\"true\">Sua equipe recebe orienta\u00e7\u00f5es pr\u00e1ticas antes de avan\u00e7ar com a an\u00e1lise da FDA.<\/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>\n\t\t<div class=\"elementor-element elementor-element-97a7a33 e-con-full e-flex e-con e-child\" data-id=\"97a7a33\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6b675f5 elementor-widget elementor-widget-image\" data-id=\"6b675f5\" 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 loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"673\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/FDA-package-1024x861.jpg\" class=\"attachment-large size-large wp-image-36104\" alt=\"FDA package 510k\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/FDA-package-1024x861.jpg 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/FDA-package-300x252.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/FDA-package-768x645.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/FDA-package.jpg 1090w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\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\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-985288e e-con-full e-flex e-con e-parent\" data-id=\"985288e\" data-element_type=\"container\" data-e-type=\"container\" id=\"cta\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-b872097 e-con-full e-flex e-con e-child\" data-id=\"b872097\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-0e31680 e-con-full e-flex e-con e-child\" data-id=\"0e31680\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-0141445 e-con-full e-flex e-con e-child\" data-id=\"0141445\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-54ad9f3 elementor-widget elementor-widget-heading\" data-id=\"54ad9f3\" 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\">Verifique se voc\u00ea est\u00e1 pronto para o 510(k)\n<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-18d55a8 elementor-widget elementor-widget-heading\" data-id=\"18d55a8\" 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\">Conte-nos sobre o seu dispositivo, a documenta\u00e7\u00e3o atual e a meta de entrada no mercado da FDA. A Sobel analisar\u00e1 como podemos ajudar voc\u00ea na pr\u00f3xima etapa. \n<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fcd05a7 form-check-icon elementor-icon-list--layout-inline elementor-align-center elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"fcd05a7\" 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 elementor-inline-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-inline-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\">Pr\u00f3ximos passos claros<\/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 elementor-inline-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\">Sem compromisso<\/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 elementor-inline-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\">Revis\u00e3o especializada<\/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<div class=\"elementor-element elementor-element-653eecf elementor-widget__width-initial elementor-button-align-stretch elementor-widget elementor-widget-form\" data-id=\"653eecf\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;step_next_label&quot;:&quot;Pr\\u00f3ximo&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_eu_cpsr_eng\" name=\"Formul\u00e1rio de contato - 510k\" aria-label=\"Formul\u00e1rio de contato - 510k\">\n\t\t\t<input type=\"hidden\" name=\"post_id\" value=\"34943\"\/>\n\t\t\t<input type=\"hidden\" name=\"form_id\" value=\"653eecf\"\/>\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\tNome 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 aqui\" 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\tEndere\u00e7o de e-mail\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 aqui\" 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\tN\u00famero de telefone\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 aqui\" required=\"required\" pattern=\"[0-9()#&amp;+*-=.]+\" title=\"Apenas n\u00fameros e caracteres de telefone (#, -, *, etc.) s\u00e3o aceitos.\">\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 aqui\" 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-select elementor-field-group elementor-column elementor-field-group-business_area elementor-col-100 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-business_area\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\t\u00c1rea de neg\u00f3cios\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field elementor-select-wrapper remove-before \">\n\t\t\t<div class=\"select-caret-down-wrapper\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-eicon-caret-down\" viewBox=\"0 0 571.4 571.4\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M571 393Q571 407 561 418L311 668Q300 679 286 679T261 668L11 418Q0 407 0 393T11 368 36 357H536Q550 357 561 368T571 393Z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t\t<select name=\"form_fields[business_area]\" id=\"form-field-business_area\" class=\"elementor-field-textual elementor-size-sm\" required=\"required\">\n\t\t\t\t\t\t\t\t\t<option value=\"\">Selecione uma op\u00e7\u00e3o <\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Dispositivos m\u00e9dicos\">Dispositivos m\u00e9dicos<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Cosm\u00e9ticos\">Cosm\u00e9ticos<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Diagn\u00f3stico in vitro\">Diagn\u00f3stico in vitro<\/option>\n\t\t\t\t\t\t\t<\/select>\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-textarea elementor-field-group elementor-column elementor-field-group-message elementor-col-100 elementor-field-required elementor-mark-required\">\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\tMensagem\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 aqui\" required=\"required\"><\/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; Concordo com a pol\u00edtica de privacidade de dados e com os termos e condi\u00e7\u00f5es publicados neste site<\/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; &nbsp;Concordo em receber boletins informativos quinzenais com atualiza\u00e7\u00f5es sobre o mercado regulat\u00f3rio 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_eu_cpsr_eng\">\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\">Solicitar minha an\u00e1lise 510(k)<\/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-74773bf elementor-widget elementor-widget-html\" data-id=\"74773bf\" 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 rel=\"stylesheet\" href=\"https:\/\/cdnjs.cloudflare.com\/ajax\/libs\/intl-tel-input\/17.0.8\/css\/intlTelInput.css\">\r\n\r\n<script src=\"https:\/\/cdnjs.cloudflare.com\/ajax\/libs\/intl-tel-input\/17.0.8\/js\/intlTelInput.min.js\"><\/script>\r\n\r\n<script>\r\ndocument.addEventListener(\"DOMContentLoaded\", function () {\r\n  const phoneInputs = document.querySelectorAll('input[type=\"tel\"]');\r\n\r\n  phoneInputs.forEach(function (input) {\r\n    \/\/ Prevent duplicate initialization\r\n    if (input.dataset.itiInitialized === \"true\") {\r\n      return;\r\n    }\r\n\r\n    \/\/ Also skip if Elementor \/ another script already wrapped it\r\n    if (input.closest(\".iti\")) {\r\n      return;\r\n    }\r\n\r\n    input.dataset.itiInitialized = \"true\";\r\n\r\n    \/\/ Improve mobile keyboard\r\n    input.setAttribute(\"inputmode\", \"numeric\");\r\n    input.setAttribute(\"pattern\", \"[0-9]*\");\r\n\r\n    \/\/ Allow only numbers in the visible phone field\r\n    input.addEventListener(\"input\", function () {\r\n      input.value = input.value.replace(\/\\D\/g, \"\");\r\n    });\r\n\r\n    const iti = window.intlTelInput(input, {\r\n      separateDialCode: true,\r\n      preferredCountries: [\"br\", \"us\", \"de\", \"fr\"],\r\n      initialCountry: \"br\",\r\n      hiddenInput: \"full\",\r\n      utilsScript:\r\n        \"https:\/\/cdnjs.cloudflare.com\/ajax\/libs\/intl-tel-input\/17.0.8\/js\/utils.js\"\r\n    });\r\n\r\n    const form = input.closest(\"form\");\r\n\r\n    if (!form) {\r\n      return;\r\n    }\r\n\r\n    form.addEventListener(\"submit\", function (event) {\r\n      \/\/ Clean again before submit\r\n      input.value = input.value.replace(\/\\D\/g, \"\");\r\n\r\n      if (!iti.isValidNumber()) {\r\n        event.preventDefault();\r\n        alert(\"Please enter a valid phone number.\");\r\n        input.focus();\r\n        return;\r\n      }\r\n\r\n      input.value = iti.getNumber();\r\n    });\r\n  });\r\n});\r\n<\/script>\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>\n\t\t<div class=\"elementor-element elementor-element-4ce9a22 e-flex e-con-boxed e-con e-parent\" data-id=\"4ce9a22\" 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-dceec13 e-con-full e-flex e-con e-child\" data-id=\"dceec13\" 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-9c01286 elementor-widget elementor-widget-heading\" data-id=\"9c01286\" 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\">Perguntas frequentes<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dfea964 elementor-widget elementor-widget-toggle\" data-id=\"dfea964\" 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-2341\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-2341\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M31.3 192h257.3c17.8 0 26.7 21.5 14.1 34.1L174.1 354.8c-7.8 7.8-20.5 7.8-28.3 0L17.2 226.1C4.6 213.5 13.5 192 31.3 192z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Para que tipo de empresa \u00e9 esse servi\u00e7o?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2341\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-2341\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"The best time is before the 510(k) package is fully assembled, especially if route, predicate, claims, evidence or eSTAR structure are still uncertain.\"}]\" data-inline-monday=\"true\">Esse suporte \u00e9 melhor para empresas de dispositivos m\u00e9dicos com um produto definido, documenta\u00e7\u00e3o em andamento e um plano para entrar ou operar no mercado dos EUA.<\/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-2342\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-2342\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M31.3 192h257.3c17.8 0 26.7 21.5 14.1 34.1L174.1 354.8c-7.8 7.8-20.5 7.8-28.3 0L17.2 226.1C4.6 213.5 13.5 192 31.3 192z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Precisamos estar prontos para enviar?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2342\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-2342\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"That is a common starting point. Sobel helps evaluate candidate predicates and organize the rationale for the option that best supports your substantial equivalence case.\"}]\" data-inline-monday=\"true\">A Sobel pode dar suporte \u00e0s empresas antes do envio, analisando o caminho, as lacunas na documenta\u00e7\u00e3o, a estrat\u00e9gia de predicados e os riscos de prepara\u00e7\u00e3o. <\/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-2343\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-2343\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M31.3 192h257.3c17.8 0 26.7 21.5 14.1 34.1L174.1 354.8c-7.8 7.8-20.5 7.8-28.3 0L17.2 226.1C4.6 213.5 13.5 192 31.3 192z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">A Sobel pode ajudar se voc\u00ea n\u00e3o tiver certeza sobre o caminho correto do FDA?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2343\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-2343\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"The right route depends on your device, predicate, intended use, technological differences and available evidence. We help assess whether a Traditional, Special or Safety &#038; Performance Based 510(k) is the most appropriate path.\"}]\" data-inline-monday=\"true\">Sim. Podemos analisar as informa\u00e7\u00f5es do seu dispositivo, o uso pretendido e a posi\u00e7\u00e3o regulat\u00f3ria para ajudar a esclarecer as pr\u00f3ximas etapas mais adequadas. <\/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-2344\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-2344\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M31.3 192h257.3c17.8 0 26.7 21.5 14.1 34.1L174.1 354.8c-7.8 7.8-20.5 7.8-28.3 0L17.2 226.1C4.6 213.5 13.5 192 31.3 192z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Este \u00e9 um modelo, um curso ou um guia de 510(k) feito por voc\u00ea mesmo?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2344\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-2344\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"We review the logic before the file is finalized, align claims with evidence, organize comparison tables and check whether eSTAR and RTA expectations have been addressed.\"}]\" data-inline-monday=\"true\">N\u00e3o. Trata-se de suporte regulat\u00f3rio profissional para empresas que est\u00e3o preparando um dispositivo m\u00e9dico real para an\u00e1lise da FDA. <\/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-2345\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-2345\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M31.3 192h257.3c17.8 0 26.7 21.5 14.1 34.1L174.1 354.8c-7.8 7.8-20.5 7.8-28.3 0L17.2 226.1C4.6 213.5 13.5 192 31.3 192z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">A Sobel pode ajudar os fabricantes estrangeiros a entrar no mercado dos EUA?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2345\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-2345\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Yes. We can review the current structure, identify weak points in the SE rationale and help organize the content into a clearer eSTAR-ready package.\"}]\" data-inline-monday=\"true\">Sim. A Sobel d\u00e1 suporte a empresas internacionais com estrat\u00e9gia regulat\u00f3ria da FDA, revis\u00e3o de documenta\u00e7\u00e3o, registro, listagem e planejamento de entrada no mercado. <\/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-2346\" class=\"elementor-tab-title\" data-tab=\"6\" role=\"button\" aria-controls=\"elementor-tab-content-2346\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M31.3 192h257.3c17.8 0 26.7 21.5 14.1 34.1L174.1 354.8c-7.8 7.8-20.5 7.8-28.3 0L17.2 226.1C4.6 213.5 13.5 192 31.3 192z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">O que voc\u00ea deve ter antes de entrar em contato com a Sobel?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2346\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"6\" role=\"region\" aria-labelledby=\"elementor-tab-title-2346\"><p>O ideal \u00e9 que voc\u00ea tenha um produto definido, uso pretendido, mercado-alvo, informa\u00e7\u00f5es do fabricante e, pelo menos, alguma documenta\u00e7\u00e3o t\u00e9cnica ou regulat\u00f3ria.<\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t<script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Para que tipo de empresa \\u00e9 esse servi\\u00e7o?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p class=\\\"monday-block-1\\\" contenteditable=\\\"true\\\" data-monday-block-type=\\\"1\\\" data-monday-block-content=\\\"[{\\\"insert\\\":\\\"The best time is before the 510(k) package is fully assembled, especially if route, predicate, claims, evidence or eSTAR structure are still uncertain.\\\"}]\\\" data-inline-monday=\\\"true\\\">Esse suporte \\u00e9 melhor para empresas de dispositivos m\\u00e9dicos com um produto definido, documenta\\u00e7\\u00e3o em andamento e um plano para entrar ou operar no mercado dos EUA.<\\\/p>\\n\"}},{\"@type\":\"Question\",\"name\":\"Precisamos estar prontos para enviar?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p class=\\\"monday-block-1\\\" contenteditable=\\\"true\\\" data-monday-block-type=\\\"1\\\" data-monday-block-content=\\\"[{\\\"insert\\\":\\\"That is a common starting point. Sobel helps evaluate candidate predicates and organize the rationale for the option that best supports your substantial equivalence case.\\\"}]\\\" data-inline-monday=\\\"true\\\">A Sobel pode dar suporte \\u00e0s empresas antes do envio, analisando o caminho, as lacunas na documenta\\u00e7\\u00e3o, a estrat\\u00e9gia de predicados e os riscos de prepara\\u00e7\\u00e3o. <\\\/p>\\n\"}},{\"@type\":\"Question\",\"name\":\"A Sobel pode ajudar se voc\\u00ea n\\u00e3o tiver certeza sobre o caminho correto do FDA?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p class=\\\"monday-block-1\\\" contenteditable=\\\"true\\\" data-monday-block-type=\\\"1\\\" data-monday-block-content=\\\"[{\\\"insert\\\":\\\"The right route depends on your device, predicate, intended use, technological differences and available evidence. We help assess whether a Traditional, Special or Safety &#038; Performance Based 510(k) is the most appropriate path.\\\"}]\\\" data-inline-monday=\\\"true\\\">Sim. Podemos analisar as informa\\u00e7\\u00f5es do seu dispositivo, o uso pretendido e a posi\\u00e7\\u00e3o regulat\\u00f3ria para ajudar a esclarecer as pr\\u00f3ximas etapas mais adequadas. <\\\/p>\\n\"}},{\"@type\":\"Question\",\"name\":\"Este \\u00e9 um modelo, um curso ou um guia de 510(k) feito por voc\\u00ea mesmo?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p class=\\\"monday-block-1\\\" contenteditable=\\\"true\\\" data-monday-block-type=\\\"1\\\" data-monday-block-content=\\\"[{\\\"insert\\\":\\\"We review the logic before the file is finalized, align claims with evidence, organize comparison tables and check whether eSTAR and RTA expectations have been addressed.\\\"}]\\\" data-inline-monday=\\\"true\\\">N\\u00e3o. Trata-se de suporte regulat\\u00f3rio profissional para empresas que est\\u00e3o preparando um dispositivo m\\u00e9dico real para an\\u00e1lise da FDA. <\\\/p>\\n\"}},{\"@type\":\"Question\",\"name\":\"A Sobel pode ajudar os fabricantes estrangeiros a entrar no mercado dos EUA?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p class=\\\"monday-block-1\\\" contenteditable=\\\"true\\\" data-monday-block-type=\\\"1\\\" data-monday-block-content=\\\"[{\\\"insert\\\":\\\"Yes. We can review the current structure, identify weak points in the SE rationale and help organize the content into a clearer eSTAR-ready package.\\\"}]\\\" data-inline-monday=\\\"true\\\">Sim. A Sobel d\\u00e1 suporte a empresas internacionais com estrat\\u00e9gia regulat\\u00f3ria da FDA, revis\\u00e3o de documenta\\u00e7\\u00e3o, registro, listagem e planejamento de entrada no mercado. <\\\/p>\\n\"}},{\"@type\":\"Question\",\"name\":\"O que voc\\u00ea deve ter antes de entrar em contato com a Sobel?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>O ideal \\u00e9 que voc\\u00ea tenha um produto definido, uso pretendido, mercado-alvo, informa\\u00e7\\u00f5es do fabricante e, pelo menos, alguma documenta\\u00e7\\u00e3o t\\u00e9cnica ou regulat\\u00f3ria.<\\\/p>\\n\"}}]}<\/script>\n\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\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-69db787 e-flex e-con-boxed e-con e-parent\" data-id=\"69db787\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-eae0917 elementor-widget elementor-widget-theme-site-logo elementor-widget-image\" data-id=\"eae0917\" 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-4522\" 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-055a371 elementor-widget elementor-widget-heading\" data-id=\"055a371\" 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\/pt-br\/declaracao-de-privacidade-br\/\" target=\"_blank\">Pol\u00edtica de Privacidade<\/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>A Sobel ajuda as empresas de dispositivos m\u00e9dicos a alinhar a estrat\u00e9gia de predicados, reivindica\u00e7\u00f5es, evid\u00eancias e estrutura eSTAR antes que o pacote 510(k) avance.<\/p>\n","protected":false},"author":16,"featured_media":0,"parent":36579,"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-34943","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v28.1) - 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