{"id":47355,"date":"2026-11-01T19:51:18","date_gmt":"2026-11-01T22:51:18","guid":{"rendered":"https:\/\/sobelconsult.com\/home\/nuestras-soluciones-2\/estados-unidos\/"},"modified":"2026-11-01T19:53:25","modified_gmt":"2026-11-01T22:53:25","slug":"estados-unidos","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/es\/home\/nuestras-soluciones-2\/estados-unidos\/","title":{"rendered":"Estados Unidos"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"47355\" class=\"elementor elementor-47355 elementor-47212\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3973c3f e-flex e-con-boxed e-con e-child\" data-id=\"3973c3f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dcd2d90 elementor-widget elementor-widget-html\" data-id=\"dcd2d90\" 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<div class=\"sbm\">\n<nav class=\"sbm-crumb sb-crumb\" aria-label=\"Breadcrumb\"><a href=\"\/\">Inicio<\/a><span aria-hidden=\"true\">\u203a<\/span><a href=\"https:\/\/sobelconsult.com\/es\/home\/nuestras-soluciones-2\/\">Soluciones<\/a><span aria-hidden=\"true\">\u203a<\/span><span aria-current=\"page\">Estados Unidos<\/span><\/nav>\n<div class=\"sbm-grid\">\n<div class=\"sbm-txt\">\n<p class=\"sbm-eye\">Productos sanitarios \u00b7 Cosm\u00e9ticos<\/p>\n<h1 class=\"sbm-h1\">Tu ruta regulatoria en <span class=\"sbm-gold\">Estados Unidos<\/span>.<\/h1>\n<p class=\"sbm-lead\">Los productos sanitarios y los cosm\u00e9ticos est\u00e1n regulados por la FDA. Definimos tu proceso, preparamos tu documentaci\u00f3n y actuamos como tu agente en EE. UU.<\/p>\n<div class=\"sbm-ctas\"><a class=\"sbm-btn\" href=\"#footer-cta\">Reservar mi evaluaci\u00f3n<\/a><a class=\"sbm-link\" href=\"#us-products\">Elige tu producto \u2192<\/a><\/div>\n<p class=\"sbm-trust\">Productos sanitarios \u00b7 Cosm\u00e9ticos \u00b7 Certificados seg\u00fan la norma ISO 9001 en Brasil \u00b7 Servicio en PT \u00b7 EN \u00b7 DE<\/p>\n<\/div>\n<div class=\"sbm-photo\"><img fetchpriority=\"high\" decoding=\"async\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-market-usa-capitol.png\" alt=\"El Capitolio de Estados Unidos en Washington, D.C., con la bandera estadounidense a la hora dorada\" width=\"1184\" height=\"896\" fetchpriority=\"high\"><\/div>\n<\/div>\n<\/div>\n<style>\n.sbm{font-family:'Host Grotesk',system-ui,sans-serif;color:#2B2E34;padding-top:17px}\n.sbm .sbm-crumb{display:flex;align-items:center;gap:8px;margin:0 0 32px;font-size:14px;line-height:20px;color:#4F535B;white-space:nowrap;min-width:0}\n.sbm .sbm-crumb a{color:#4F535B;text-decoration:none;font-weight:400;font-size:inherit;line-height:inherit;font-family:inherit}\n.sbm .sbm-crumb a:hover,.sbm .sbm-crumb a:focus{color:#051B5A;text-decoration:underline}\n.sbm .sbm-crumb [aria-current]{color:#051B5A;font-weight:600;overflow:hidden;text-overflow:ellipsis;min-width:0}\n.sbm-grid{display:flex;gap:48px;align-items:stretch}\n.sbm-txt{flex:1 1 55%;display:flex;flex-direction:column;min-width:0}\n.sbm .sbm-eye{display:flex;align-items:center;gap:10px;margin:0;font-size:13px;font-weight:600;letter-spacing:.16em;text-transform:uppercase;color:#051B5A;line-height:1.4}\n.sbm .sbm-eye:before{content:\"\";flex:0 0 9px;width:9px;height:9px;border-radius:50%;background:#F2B705}\n.sbm h1.sbm-h1{font-family:Lora,Georgia,serif;font-weight:700;font-size:50px;line-height:1.12;color:#051B5A;margin:22px 0 0;letter-spacing:0;text-transform:none}\n.sbm .sbm-gold{color:#F2B705}\n.sbm .sbm-lead{font-size:20px;line-height:1.55;color:#051B5A;margin:26px 0 0}\n.sbm-ctas{display:flex;flex-wrap:wrap;align-items:center;gap:24px;margin-top:32px}\n.sbm .sbm-btn{display:inline-flex;align-items:center;justify-content:center;min-height:52px;background:#F2B705;color:#3A2B00;font-weight:600;font-size:16px;line-height:1.3;padding:14px 28px;border-radius:999px;text-decoration:none;border:0;text-align:center}\n.sbm .sbm-btn:hover,.sbm .sbm-btn:focus{background:#E0A800;color:#3A2B00}\n.sbm .sbm-link{font-weight:600;font-size:18px;color:#051B5A;text-decoration:underline;text-decoration-color:#F2B705;text-underline-offset:4px}\n.sbm .sbm-link:hover,.sbm .sbm-link:focus{color:#051B5A;text-decoration-thickness:2px}\n.sbm .sbm-trust{font-size:14px;line-height:1.5;color:#4F535B;margin:36px 0 0}\n.sbm-photo{flex:0 1 45%;position:relative;min-height:320px;border-radius:22px;overflow:hidden;box-shadow:0 12px 32px rgba(7,31,99,.12)}\n.sbm-photo img{position:absolute;inset:0;width:100%!important;height:100%!important;max-width:none!important;object-fit:cover;object-position:50% 50%;border-radius:22px}\n@media (max-width:1024px){.sbm h1.sbm-h1{font-size:42px}.sbm-grid{gap:32px}}\n@media (min-width:1025px) and (max-height:840px){.sbm h1.sbm-h1{font-size:42px}.sbm .sbm-lead{margin-top:20px}.sbm-ctas{margin-top:28px}.sbm .sbm-trust{margin-top:28px}}\n@media (max-width:860px){.sbm-grid{flex-direction:column}.sbm-photo{flex-basis:auto;width:100%;min-height:0;height:300px}}\n@media (max-width:767px){.sbm{padding-top:0}.sbm .sbm-crumb{margin-bottom:20px;font-size:13px}.sbm-txt{text-align:center}.sbm-txt .sbm-eye{justify-content:center}.sbm h1.sbm-h1{font-size:32px;margin-top:16px}.sbm .sbm-lead{font-size:18px;margin-top:20px}.sbm-ctas{flex-direction:column;gap:12px;margin-top:24px}.sbm .sbm-btn{width:100%}.sbm .sbm-trust{margin-top:24px}.sbm-photo{height:240px}}\n<\/style>\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-43b7688 e-flex e-con-boxed e-con e-parent\" data-id=\"43b7688\" 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-f78be9d e-con-full e-flex e-con e-child\" data-id=\"f78be9d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7cdaacd elementor-widget elementor-widget-heading\" data-id=\"7cdaacd\" 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\">DE D\u00d3NDE VIENES<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-75e1abf elementor-widget elementor-widget-heading\" data-id=\"75e1abf\" 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\">Dos puntos de partida, un mercado<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-75ffb3a e-con-full e-flex e-con e-child\" data-id=\"75ffb3a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-bff56ef e-con-full e-flex e-con e-child\" data-id=\"bff56ef\" 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-0ba9d0f elementor-widget elementor-widget-heading\" data-id=\"0ba9d0f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Primera vez en EE. UU.<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-abb103b elementor-widget elementor-widget-text-editor\" data-id=\"abb103b\" 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>Est\u00e1s fuera de Estados Unidos y quieres llegar a los clientes estadounidenses con un plan claro.<\/p><ul class=\"sb-li\" style=\"margin:12px 0 0;padding-left:18px;color:#2B2E34;line-height:1.7\"><li>Tu v\u00eda de autorizaci\u00f3n ante la FDA ya est\u00e1 definida: 510(k), De Novo o PMA<\/li><li>Registro de la empresa, con Sobel como tu agente en EE. UU.<\/li><li>Cosm\u00e9ticos: registro MoCRA, inclusi\u00f3n en la lista y justificaci\u00f3n de la seguridad<\/li><\/ul>\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-678f419 e-con-full e-flex e-con e-child\" data-id=\"678f419\" 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-eed8928 elementor-widget elementor-widget-heading\" data-id=\"eed8928\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Ya est\u00e1 aprobado en otro mercado<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7319913 elementor-widget elementor-widget-text-editor\" data-id=\"7319913\" 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>Tu producto ya est\u00e1 en el mercado en Brasil o en Europa y Estados Unidos es tu pr\u00f3ximo paso.<\/p><ul class=\"sb-li\" style=\"margin:12px 0 0;padding-left:18px;color:#2B2E34;line-height:1.7\"><li>\u00bfQu\u00e9 partes de tu expediente de la ANVISA o de la CE puedes reutilizar?<\/li><li>Discrepancias con respecto a las normas de la FDA y el QMSR, basadas en la norma ISO 13485<\/li><li>Etiquetas y declaraciones adaptadas a los requisitos de EE. UU.<\/li><\/ul>\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-2c6782d e-flex e-con-boxed e-con e-parent\" data-id=\"2c6782d\" data-element_type=\"container\" data-e-type=\"container\" id=\"us-products\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a296a85 animated-slow elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"a296a85\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;,&quot;_animation_delay&quot;:200}\" 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\">\u00bfQu\u00e9 vas a llevar a EE. UU.?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-dc1e849 e-flex e-con-boxed e-con e-child\" data-id=\"dc1e849\" data-element_type=\"container\" data-e-type=\"container\" id=\"regulatory-path\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-56a071b animated-slow elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"56a071b\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;,&quot;_animation_delay&quot;:400}\" 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\">Cada producto sigue sus propias normas de la FDA. Elige el tuyo para ver el proceso completo.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-8c191d6 sobel-solutions-section e-con-full e-flex e-con e-child\" data-id=\"8c191d6\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;none&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-8b9033b e-con-full e-flex e-con e-child\" data-id=\"8b9033b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-1d29157 e-con-full e-flex e-con e-child\" data-id=\"1d29157\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4ace369 elementor-widget elementor-widget-image\" data-id=\"4ace369\" 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=\"800\" height=\"534\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-md_card_dental-implant_gloved-hand-1024x683.webp\" class=\"attachment-large size-large wp-image-47092\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-md_card_dental-implant_gloved-hand-1024x683.webp 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-md_card_dental-implant_gloved-hand-300x200.webp 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-md_card_dental-implant_gloved-hand-768x512.webp 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-md_card_dental-implant_gloved-hand.webp 1248w\" 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<div class=\"elementor-element elementor-element-5ddef11 e-con-full icone-segmento e-flex e-con e-child\" data-id=\"5ddef11\" 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-718a074 elementor-widget elementor-widget-image\" data-id=\"718a074\" 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=\"500\" height=\"500\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/4-4.png\" class=\"attachment-large size-large wp-image-47096\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/4-4.png 500w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/4-4-300x300.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/4-4-150x150.png 150w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/>\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-f6bb005 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"f6bb005\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Productos sanitarios<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-223c9b7 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"223c9b7\" 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>Equipos, implantes y software, desde la elecci\u00f3n de la v\u00eda hasta la presentaci\u00f3n del expediente a la FDA.<\/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-bca47e9 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"bca47e9\" 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-grow\" href=\"https:\/\/sobelconsult.com\/es\/our-solutions-usa\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<i aria-hidden=\"true\" class=\" arrow_right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Productos sanitarios en EE. UU.<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d39bd55 e-con-full e-flex e-con e-child\" data-id=\"d39bd55\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-d41995f e-con-full e-flex e-con e-child\" data-id=\"d41995f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;,&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_scale_effect&quot;:&quot;yes&quot;,&quot;motion_fx_scale_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;motion_fx_scale_direction&quot;:&quot;out-in&quot;,&quot;motion_fx_scale_range&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:20,&quot;end&quot;:80}},&quot;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet&quot;,&quot;mobile&quot;]}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-524afc4 elementor-widget elementor-widget-image\" data-id=\"524afc4\" 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=\"800\" height=\"534\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-cos_card_serum-dropper_hand-1024x683.webp\" class=\"attachment-large size-large wp-image-47100\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-cos_card_serum-dropper_hand-1024x683.webp 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-cos_card_serum-dropper_hand-300x200.webp 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-cos_card_serum-dropper_hand-768x512.webp 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-cos_card_serum-dropper_hand.webp 1248w\" 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<div class=\"elementor-element elementor-element-caee5a2 e-con-full icone-segmento e-flex e-con e-child\" data-id=\"caee5a2\" 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-1471874 elementor-widget elementor-widget-image\" data-id=\"1471874\" 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=\"500\" height=\"500\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/5-4.png\" class=\"attachment-large size-large wp-image-47104\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/5-4.png 500w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/5-4-300x300.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/5-4-150x150.png 150w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/>\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-e067318 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"e067318\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Cosm\u00e9ticos<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-558b144 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"558b144\" 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>Cuidado de la piel, maquillaje y cuidado personal: desde el registro en MoCRA hasta el etiquetado.<\/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-8a60370 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"8a60370\" 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-grow\" href=\"https:\/\/sobelconsult.com\/es\/registro-de-cosmeticos-en-estados-unidos\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<i aria-hidden=\"true\" class=\" arrow_right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Los cosm\u00e9ticos en EE. UU.<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-268b121 e-flex e-con-boxed e-con e-parent\" data-id=\"268b121\" data-element_type=\"container\" data-e-type=\"container\" id=\"local-presence\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-65d4d5f elementor-widget elementor-widget-html\" data-id=\"65d4d5f\" 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<div class=\"sbg\" id=\"us-services\">\n<p class=\"sbg-ey\" data-k=\"ey\">SERVICIOS EN ESTADOS UNIDOS<\/p>\n<h2 class=\"sbg-h\" data-k=\"h\">Todo lo que hacemos para el mercado estadounidense<\/h2>\n<p class=\"sbg-sub\" data-k=\"sub\">Estrategia, documentaci\u00f3n y representaci\u00f3n ante la FDA, todo en un mismo equipo.<\/p>\n<div class=\"sbg-f\" role=\"group\" aria-label=\"Filter by product\">\n<button type=\"button\" class=\"sbg-c on\" data-f=\"all\" data-k=\"all\">Todos<\/button>\n<button type=\"button\" class=\"sbg-c\" data-f=\"md\"><span class=\"sbg-d\" style=\"background:#2A72C8\"><\/span><span data-k=\"md\">Productos sanitarios<\/span><\/button>\n<button type=\"button\" class=\"sbg-c\" data-f=\"co\"><span class=\"sbg-d\" style=\"background:#9471CF\"><\/span><span data-k=\"co\">Cosm\u00e9ticos<\/span><\/button>\n<\/div>\n<div class=\"sbg-g\">\n<a class=\"sbg-t\" data-s=\"md\" href=\"https:\/\/sobelconsult.com\/es\/regulatorio-calidad\/#registration\"><h3 data-k=\"t1\">Estrategia regulatoria y v\u00eda de tramitaci\u00f3n ante la FDA<\/h3><p data-k=\"d1\">Clasificaci\u00f3n, c\u00f3digo de producto y la v\u00eda adecuada: 510(k), De Novo o PMA.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"md\" href=\"https:\/\/sobelconsult.com\/es\/our-solutions-usa\/fda-medical-device-regulatory-consulting\/\"><h3 data-k=\"t2\">Solicitudes 510(k), De Novo y PMA<\/h3><p data-k=\"d2\">Expediente de solicitud y respuestas a las solicitudes de la FDA.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"md\" href=\"https:\/\/sobelconsult.com\/es\/regulatorio-calidad\/#quality-systems\"><h3 data-k=\"t3\">Sistema de calidad (QMSR)<\/h3><p data-k=\"d3\">21 CFR 820, ahora en consonancia con la norma ISO 13485, adem\u00e1s de auditor\u00edas.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"md\" href=\"https:\/\/sobelconsult.com\/es\/evidencia-clinica-seguridad-producto\/#biological-evaluation\"><h3 data-k=\"t4\">Evaluaci\u00f3n biol\u00f3gica y cl\u00ednica<\/h3><p data-k=\"d4\">Norma ISO 10993 y evidencia cl\u00ednica para la FDA.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"co\" href=\"https:\/\/sobelconsult.com\/es\/registro-de-cosmeticos-en-estados-unidos\/registro-de-instalaciones-cosmeticas-fda-mocra\/\"><h3 data-k=\"t5\">Registro y inclusi\u00f3n en la lista de la MoCRA<\/h3><p data-k=\"d5\">Registro de instalaciones y lista de productos ante la FDA.<\/p><span class=\"sbg-tg\"><i class=\"co\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"co\" href=\"https:\/\/sobelconsult.com\/es\/registro-de-cosmeticos-en-estados-unidos\/justificacion-de-seguridad-de-la-fda\/\"><h3 data-k=\"t6\">Justificaci\u00f3n de la seguridad y etiquetado<\/h3><p data-k=\"d6\">Pruebas de seguridad y etiquetas que cumplan con las normas de la FDA.<\/p><span class=\"sbg-tg\"><i class=\"co\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"md co\" href=\"https:\/\/sobelconsult.com\/es\/our-solutions-usa\/fda-us-agent\/\" data-hco=\"\/our-solutions-cosmetics-usa\/fda-agent-service-for-cosmetics\/\"><h3 data-k=\"t7\">Agente en EE. UU.<\/h3><p data-k=\"d7\">Sobel act\u00faa como tu agente en EE. UU. ante la FDA.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><i class=\"co\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"md co\" href=\"https:\/\/sobelconsult.com\/es\/como-trabajamos\/#shw-models\"><h3 data-k=\"t8\">Asistencia continua<\/h3><p data-k=\"d8\">Asistencia mensual para cambios, renovaciones y novedades de la FDA.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><i class=\"co\"><\/i><\/span><\/a>\n<\/div>\n<\/div>\n<style>\n.sbg{max-width:1200px;margin:0 auto;font-family:'Host Grotesk',sans-serif;color:#2B2E34;text-align:center;scroll-margin-top:94px}\n.sbg-ey{display:inline-flex;align-items:center;gap:12px;margin:0;font-size:13px;font-weight:600;letter-spacing:.16em;color:#051B5A}\n.sbg-ey:before{content:\"\";width:9px;height:9px;border-radius:50%;background:#F2B705}\n.sbg-h{margin:20px 0 0;font-family:'Lora',Georgia,serif;font-weight:700;font-size:40px;line-height:1.15;color:#051B5A}\n.sbg-sub{margin:24px auto 0;max-width:760px;font-size:18px;line-height:1.55}\n.sbg-f{display:flex;flex-wrap:wrap;justify-content:center;gap:12px;margin-top:28px}\n.sbg-c{font:600 16px 'Host Grotesk',sans-serif;display:inline-flex;align-items:center;gap:8px;min-height:44px;padding:10px 20px;border-radius:999px;border:1.5px solid #CBD1E3;background:#FFFFFF;color:#051B5A;cursor:pointer;transition:all .2s ease}\n.sbg-d{width:10px;height:10px;border-radius:50%;display:inline-block}\n.sbg-g{display:grid;grid-template-columns:repeat(4,minmax(0,1fr));gap:20px;margin-top:28px;text-align:left}\n.sbg-t{display:flex;flex-direction:column;gap:10px;background:#FFFFFF;border:1px solid #E2DCD1;border-top:5px solid #E2DCD1;border-radius:18px;padding:20px 22px;text-decoration:none;box-shadow:0 1px 2px rgba(5,27,90,.08);transition:transform .25s ease,box-shadow .25s ease,opacity .25s ease,border-color .25s ease}\n.sbg .sbg-t:hover,.sbg .sbg-t:focus{transform:translateY(-3px);box-shadow:0 12px 28px rgba(5,27,90,.12)}\n.sbg-t h3{margin:0;font-size:18px;font-weight:700;line-height:1.3;color:#051B5A}\n.sbg-t p{margin:0;font-size:15px;line-height:1.5;color:#4F535B}\n.sbg-tg{display:flex;gap:6px;margin-top:auto;padding-top:6px}\n.sbg-tg i{width:28px;height:6px;border-radius:4px}\n.sbg-tg .md{background:#2A72C8}.sbg-tg .iv{background:#149189}.sbg-tg .co{background:#9471CF}\n.sbg-t.off{opacity:.25}\n@media(max-width:1024px){.sbg-g{grid-template-columns:repeat(2,minmax(0,1fr))}}\n@media(max-width:767px){.sbg-h{font-size:28px}.sbg-sub{font-size:16px}.sbg-g{grid-template-columns:minmax(0,1fr);gap:16px}.sbg-f{gap:8px}.sbg-c{padding:8px 14px;font-size:15px}.sbg-t.off{display:none}.sbg{scroll-margin-top:71px}}\n<\/style>\n<script>\n(function(){\nvar T={\npt:{ey:\"SERVI\u00c7OS NOS ESTADOS UNIDOS\",h:\"Tudo o que fazemos para o mercado americano\",sub:\"Estrat\u00e9gia, documenta\u00e7\u00e3o e representa\u00e7\u00e3o perante a FDA, em uma s\u00f3 equipe.\",all:\"Todos\",md:\"Dispositivos m\u00e9dicos\",co:\"Cosm\u00e9ticos\",\nt1:\"Estrat\u00e9gia regulat\u00f3ria e caminho na FDA\",d1:\"Classifica\u00e7\u00e3o, c\u00f3digo de produto e o caminho certo: 510(k), De Novo ou PMA.\",\nt2:\"Submiss\u00f5es 510(k), De Novo e PMA\",d2:\"Dossi\u00ea de submiss\u00e3o e respostas \u00e0s solicita\u00e7\u00f5es da FDA.\",\nt3:\"Sistema da qualidade (QMSR)\",d3:\"21 CFR 820, agora alinhado \u00e0 ISO 13485, e auditorias.\",\nt4:\"Avalia\u00e7\u00e3o biol\u00f3gica e cl\u00ednica\",d4:\"ISO 10993 e evid\u00eancia cl\u00ednica para a FDA.\",\nt5:\"Registro e listagem MoCRA\",d5:\"Registro do estabelecimento e listagem dos produtos na FDA.\",\nt6:\"Comprova\u00e7\u00e3o de seguran\u00e7a e rotulagem\",d6:\"Evid\u00eancias de seguran\u00e7a e r\u00f3tulos conforme as regras da FDA.\",\nt7:\"U.S. Agent\",d7:\"A Sobel atua como seu U.S. Agent perante a FDA.\",\nt8:\"Suporte cont\u00ednuo\",d8:\"Acompanhamento mensal de altera\u00e7\u00f5es, renova\u00e7\u00f5es e novidades da FDA.\"},\nes:{ey:\"SERVICIOS EN ESTADOS UNIDOS\",h:\"Todo lo que hacemos para el mercado estadounidense\",sub:\"Estrategia, documentaci\u00f3n y representaci\u00f3n ante la FDA, en un solo equipo.\",all:\"Todos\",md:\"Productos sanitarios\",co:\"Cosm\u00e9ticos\",\nt1:\"Estrategia regulatoria y v\u00eda ante la FDA\",d1:\"Clasificaci\u00f3n, c\u00f3digo de producto y la v\u00eda correcta: 510(k), De Novo o PMA.\",\nt2:\"Solicitudes 510(k), De Novo y PMA\",d2:\"Expediente de solicitud y respuestas a los requerimientos de la FDA.\",\nt3:\"Sistema de calidad (QMSR)\",d3:\"21 CFR 820, ahora alineado con ISO 13485, y auditor\u00edas.\",\nt4:\"Evaluaci\u00f3n biol\u00f3gica y cl\u00ednica\",d4:\"ISO 10993 y evidencia cl\u00ednica para la FDA.\",\nt5:\"Registro y listado MoCRA\",d5:\"Registro del establecimiento y listado de productos ante la FDA.\",\nt6:\"Sustento de seguridad y etiquetado\",d6:\"Evidencia de seguridad y etiquetas conforme a las reglas de la FDA.\",\nt7:\"Agente en EE. 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.elementor-element.elementor-element-caee5a2{width:76px!important;max-width:76px!important;--width:76px;align-self:center!important;margin:-38px auto 6px!important}\n.elementor .elementor-element-2c6782d .elementor-element-5ddef11 img,.elementor .elementor-element-2c6782d .elementor-element-caee5a2 img{width:76px!important;height:76px!important}\n.sbg .sbg-sub{margin-top:14px}\n.sbg .sbg-f{margin-top:20px}\n.sbg .sbg-g{grid-template-columns:repeat(2,minmax(0,1fr));gap:10px;margin-top:20px}\n.sbg .sbg-t{padding:14px 12px;gap:8px;border-radius:14px}\n.sbg .sbg-t h3{font-size:15px;line-height:1.3}\n.sbg .sbg-t p{display:none}\n.sbg .sbg-tg i{width:20px;height:5px}\n.sbg .sbg-c{padding:6px 12px;min-height:40px;font-size:14px}\n}\n<\/style>\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-2ed0715 e-flex e-con-boxed e-con e-parent\" data-id=\"2ed0715\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e15dd9a elementor-widget elementor-widget-html\" data-id=\"e15dd9a\" 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<div class=\"sbs2\"><a href=\"https:\/\/sobelconsult.com\/es\/home\/nuestras-soluciones-2\/#sr-guide\" class=\"sbs2-c\"><span class=\"sbs2-i\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"26\" height=\"26\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"#F2B705\" stroke-width=\"1.8\" stroke-linecap=\"round\" stroke-linejoin=\"round\" aria-hidden=\"true\"><circle cx=\"6\" cy=\"19\" r=\"3\"><\/circle><path d=\"M9 19h8.5a3.5 3.5 0 0 0 0-7h-11a3.5 3.5 0 0 1 0-7H15\"><\/path><circle cx=\"18\" cy=\"5\" r=\"3\"><\/circle><\/svg><\/span><span class=\"sbs2-e\">\u00bfYA EST\u00c1 APROBADO EN OTRO LUGAR?<\/span><span class=\"sbs2-t\">Empieza por tu expediente de la ANVISA o de la CE<\/span><span class=\"sbs2-d\">Comprueba qu\u00e9 se puede reutilizar para EE. UU. antes de comprometerte con un proyecto.<\/span><span class=\"sbs2-l\">Traza tu camino con Sobel Route \u2192<\/span><\/a><a href=\"https:\/\/sobelconsult.com\/es\/our-solutions-usa\/fda-us-agent\/\" class=\"sbs2-c\"><span class=\"sbs2-i\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"26\" height=\"26\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"#F2B705\" stroke-width=\"1.8\" stroke-linecap=\"round\" stroke-linejoin=\"round\" aria-hidden=\"true\"><path d=\"M12 22s8-4 8-10V5l-8-3-8 3v7c0 6 8 10 8 10z\"><\/path><path d=\"m9 12 2 2 4-4\"><\/path><\/svg><\/span><span class=\"sbs2-e\">\u00bfNECESITAS UN AGENTE EN EE. UU.?<\/span><span class=\"sbs2-t\">Es obligatorio para las empresas de dispositivos m\u00e9dicos extranjeras<\/span><span class=\"sbs2-d\">Sobel act\u00faa como tu agente en EE. UU. ante la FDA, con un \u00fanico punto de contacto para todas tus consultas.<\/span><span class=\"sbs2-l\">Echa un vistazo al servicio de agente en EE. UU. \u2192<\/span><\/a><\/div><style>.sbs2{display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:24px;font-family:'Host Grotesk',sans-serif}.sbs2-c{display:flex;flex-direction:column;gap:10px;background:#051B5A;border-radius:18px;padding:30px;text-decoration:none;transition:transform .25s ease}.sbs2-c:hover{transform:translateY(-3px)}.sbs2-i{width:52px;height:52px;border-radius:50%;border:1.5px solid #F2B705;display:flex;align-items:center;justify-content:center}.sbs2-e{font-size:13px;font-weight:700;letter-spacing:.14em;color:#F2B705;margin-top:6px}.sbs2-t{font-family:Lora,Georgia,serif;font-weight:700;font-size:24px;line-height:1.25;color:#FFFFFF}.sbs2-d{font-size:16px;line-height:1.55;color:#D9DFEE}.sbs2-l{margin-top:auto;padding-top:8px;font-weight:600;color:#F2B705;font-size:15.5px}@media(max-width:767px){.sbs2{grid-template-columns:minmax(0,1fr)}.sbs2-t{font-size:21px}}<\/style>\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-a19c938 e-con-full e-flex e-con e-parent\" data-id=\"a19c938\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c25134c elementor-widget elementor-widget-template\" data-id=\"c25134c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"template.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-template\">\n\t\t\t\t\t<div data-elementor-type=\"container\" data-elementor-id=\"46194\" class=\"elementor elementor-46194 elementor-46189 elementor-46189\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5fc3d48 e-flex e-con-boxed e-con e-parent\" data-id=\"5fc3d48\" data-element_type=\"container\" data-e-type=\"container\" id=\"why-sobel\" 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-629f752 sbw-native e-flex e-con-boxed e-con e-child\" data-id=\"629f752\" 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-f0eb2c5 e-con-full sbw-l e-flex e-con e-child\" data-id=\"f0eb2c5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a36dc14 elementor-widget elementor-widget-heading\" data-id=\"a36dc14\" 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\">\u00bfPor qu\u00e9 Sobel?<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3c265d3 elementor-widget elementor-widget-heading\" data-id=\"3c265d3\" 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\">La normativa como una <span class=\"sbw-gold\">decisi\u00f3n<\/span> de negocio <span class=\"sbw-gold\">,<\/span> no como una lista de tareas.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-85f7a25 elementor-widget elementor-widget-text-editor\" data-id=\"85f7a25\" 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>En cada proyecto colaboran cuatro disciplinas, todas dentro del mismo equipo, desde la primera decisi\u00f3n hasta la fase posterior a la comercializaci\u00f3n.<\/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-a67f4ac e-con-full e-grid e-con e-child\" data-id=\"a67f4ac\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-693f1b5 e-con-full e-flex e-con e-child\" data-id=\"693f1b5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-85f3478 elementor-widget elementor-widget-heading\" data-id=\"85f3478\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Estrategia<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-97525b9 elementor-widget elementor-widget-text-editor\" data-id=\"97525b9\" 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>Lo primero es decidir la clasificaci\u00f3n y el orden de salida al mercado. Elegir la categor\u00eda adecuada desde el primer d\u00eda evita tener que volver a hacerlo.<\/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-6495a0a e-con-full e-flex e-con e-child\" data-id=\"6495a0a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-836adaf elementor-widget elementor-widget-heading\" data-id=\"836adaf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Ciencia propia<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-67ceef1 elementor-widget elementor-widget-text-editor\" data-id=\"67ceef1\" 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>Evaluaci\u00f3n biol\u00f3gica, cl\u00ednica y toxicol\u00f3gica realizada por nuestro propio equipo de Evidencia Cl\u00ednica y Seguridad de los Productos.<\/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-32f324f e-con-full e-flex e-con e-child\" data-id=\"32f324f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-42f4202 elementor-widget elementor-widget-heading\" data-id=\"42f4202\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Normativa, cinco mercados<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-af07af2 elementor-widget elementor-widget-text-editor\" data-id=\"af07af2\" 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>La ANVISA, la FDA, el Reglamento sobre productos sanitarios de la UE (MDR), la MHRA y Health Canada trabajaron de forma coordinada.<\/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-509c85a e-con-full e-flex e-con e-child\" data-id=\"509c85a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e1ba45f elementor-widget elementor-widget-heading\" data-id=\"e1ba45f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Tecnolog\u00eda<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2c8184f elementor-widget elementor-widget-text-editor\" data-id=\"2c8184f\" 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>Un equipo t\u00e9cnico especializado se encarga de crear los flujos de trabajo que garantizan la trazabilidad y el cumplimiento de los plazos en cada proyecto.<\/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-4d1d951 e-con-full sbw-card e-flex e-con e-child\" data-id=\"4d1d951\" 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-afde0f5 elementor-widget elementor-widget-text-editor\" data-id=\"afde0f5\" 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>\u00abSabemos c\u00f3mo piensan los auditores, porque hemos sido uno de ellos\u00bb.<\/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-4b051b4 e-con-full e-flex e-con e-child\" data-id=\"4b051b4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ed4939a elementor-widget elementor-widget-image\" data-id=\"ed4939a\" 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=\"300\" height=\"300\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-300x300.webp\" class=\"attachment-medium size-medium wp-image-44767\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-300x300.webp 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-150x150.webp 150w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-768x768.webp 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait.webp 800w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/>\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-0a86da7 e-con-full e-flex e-con e-child\" data-id=\"0a86da7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ea43503 elementor-widget elementor-widget-heading\" data-id=\"ea43503\" 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\">Maik Endler<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d696004 elementor-widget elementor-widget-heading\" data-id=\"d696004\" 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\">Fundador y director general<\/p>\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-7c430b7 elementor-widget elementor-widget-text-editor\" data-id=\"7c430b7\" 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<ul><li>Ingeniero mec\u00e1nico, formado en Alemania<\/li><li>Antiguo auditor de BSI (Organismo Notificado)<\/li><li>Experiencia en el sector en Sirona (ahora Dentsply Sirona)<\/li><\/ul>\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-87729bb elementor-align-left elementor-widget elementor-widget-button\" data-id=\"87729bb\" 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\" href=\"https:\/\/sobelconsult.com\/es\/home\/quienes-somos\/\">\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\">Conoce al equipo \u2192<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-446ce21 elementor-widget elementor-widget-html\" data-id=\"446ce21\" 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<style>.sbw-gold{color:#F2B705}.sbw-eye .elementor-heading-title{display:flex;align-items:center;gap:10px}.sbw-eye .elementor-heading-title:before{content:\"\";width:9px;height:9px;border-radius:50%;background:#F2B705;flex:none}.sbw-list ul{margin:0;padding-left:18px}.sbw-list li{margin:4px 0}.sbw-list li::marker{color:#F2B705}@media(max-width:1024px){.sbw-native > .sbw-l, .sbw-native > .sbw-card{width:100%!important}}<\/style>\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\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bd26599 e-con-full e-flex e-con e-parent\" data-id=\"bd26599\" data-element_type=\"container\" data-e-type=\"container\" id=\"faq\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bf5a530 elementor-widget elementor-widget-html\" data-id=\"bf5a530\" 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<style>\n.sbf{display:flex;flex-wrap:wrap;gap:56px;max-width:1120px;margin:0 auto;font-family:'Host Grotesk',sans-serif;color:#2B2E34}\n.sbf-intro{flex:1 1 300px;min-width:0;display:flex;flex-direction:column;gap:18px}\n.sbf-eye{margin:0;font-size:13px;font-weight:700;letter-spacing:.14em;color:#051B5A}\n.sbf-eye:before{content:\"\";display:inline-block;width:8px;height:8px;border-radius:50%;background:#F2B705;margin-right:10px;vertical-align:middle}\n.sbf-intro h2{margin:0;font-family:'Lora',Georgia,serif;font-weight:700;font-size:40px;line-height:1.15;color:#051B5A}\n.sbf-intro h2 em{font-style:normal;color:#F2B705}\n.sbf-intro p.sbf-lead{margin:0;font-size:17px;line-height:1.55}\n.sbf-btn{align-self:flex-start;background:#051B5A;color:#fff !important;text-decoration:none;border-radius:999px;padding:14px 26px;font-weight:600;font-size:16px}\n.sbf-btn:hover{background:#0E2C77}\n.sbf-list{flex:2 1 540px;min-width:0;display:flex;flex-direction:column;gap:12px}\n.sbf-item{background:#fff;border:1px solid rgba(5,27,90,.16);border-radius:14px;box-shadow:0 1px 2px rgba(5,27,90,.08);transition:box-shadow .2s}\n.sbf-item[open]{border-left:4px solid #F2B705;box-shadow:0 1px 2px rgba(5,27,90,.10),0 10px 24px rgba(5,27,90,.07)}\n.sbf-item summary{list-style:none;cursor:pointer;display:flex;justify-content:space-between;align-items:center;gap:20px;padding:20px 22px;font-size:17px;font-weight:600;color:#051B5A}\n.sbf-item summary::-webkit-details-marker{display:none}\n.sbf-item summary:focus-visible{outline:2px solid #051B5A;outline-offset:2px;border-radius:12px}\n.sbf-item summary i{flex:0 0 32px;height:32px;border-radius:50%;border:1.5px solid #D9A400;position:relative}\n.sbf-item summary i:before,.sbf-item summary i:after{content:\"\";position:absolute;left:50%;top:50%;width:12px;height:1.6px;background:#051B5A;transform:translate(-50%,-50%)}\n.sbf-item summary i:after{transform:translate(-50%,-50%) rotate(90deg);transition:transform .2s}\n.sbf-item[open] summary i:after{transform:translate(-50%,-50%) rotate(0deg)}\n.sbf-a{padding:0 22px 20px}\n.sbf-a p{margin:0;font-size:16px;line-height:1.6;color:#2B2E34;max-width:720px}\n@media(max-width:767px){.sbf-intro h2{font-size:32px}.sbf{gap:32px}}\n<\/style>\n<div class=\"sbf\">\n<div class=\"sbf-intro\"><p class=\"sbf-eye\">Preguntas frecuentes \u00b7 ESTADOS UNIDOS<\/p><h2>\u00bfQu\u00e9 te preguntan las empresas antes de entrar en <em>EE. UU.<\/em>?<\/h2><p class=\"sbf-lead\">Respuestas breves sobre productos sanitarios y cosm\u00e9ticos. En cada p\u00e1gina de producto encontrar\u00e1s m\u00e1s detalles.<\/p><a class=\"sbf-btn\" href=\"#footer-cta\">Haz tu pregunta \u2192<\/a><\/div>\n<div class=\"sbf-list\"><details class=\"sbf-item\" open=\"\"><summary><span>\u00bfQui\u00e9n regula los productos sanitarios y los cosm\u00e9ticos en EE. UU.?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Ambos est\u00e1n regulados por la <strong>FDA<\/strong> (Administraci\u00f3n de Alimentos y Medicamentos de EE. UU.) en virtud de la Ley Federal de Alimentos, Medicamentos y Cosm\u00e9ticos. En cuanto a los cosm\u00e9ticos, la <strong>Ley de Modernizaci\u00f3n de la Regulaci\u00f3n de los Cosm\u00e9ticos de 2022 (MoCRA)<\/strong> introdujo el registro de instalaciones, el listado de productos y la justificaci\u00f3n de la seguridad.<\/p><\/div><\/details><details class=\"sbf-item\"><summary><span>\u00bfNecesito un agente en EE. UU.?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Para los productos sanitarios, s\u00ed. Las empresas extranjeras deben designar a un <strong>agente en EE. UU.<\/strong> cuando se registren en la FDA (21 CFR 807.40). Sobel act\u00faa como tu agente en EE. UU. Para los cosm\u00e9ticos, comprobamos qu\u00e9 tipo de representaci\u00f3n necesita tu caso. <a href=\"https:\/\/sobelconsult.com\/es\/our-solutions-usa\/fda-us-agent\/\">Inf\u00f3rmate sobre el servicio de agente en EE. UU.<\/a><\/p><\/div><\/details><details class=\"sbf-item\"><summary><span>\u00bfQu\u00e9 procedimiento de la FDA necesita mi dispositivo?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Depende de la clasificaci\u00f3n del dispositivo. La mayor\u00eda de los dispositivos de Clase II necesitan un <strong>510(k)<\/strong>; los nuevos dispositivos de menor riesgo sin un dispositivo de referencia pueden seguir la v\u00eda <strong>De Novo<\/strong>; y la mayor\u00eda de los dispositivos de Clase III necesitan una <strong>PMA<\/strong>. Algunos dispositivos est\u00e1n exentos de la presentaci\u00f3n previa a la comercializaci\u00f3n. Definir la v\u00eda es el primer paso.<\/p><\/div><\/details><details class=\"sbf-item\"><summary><span>\u00bfQu\u00e9 ha cambiado con el QMSR de la FDA?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Desde <strong>el 2 de febrero de 2026<\/strong>, el Reglamento sobre el Sistema de Gesti\u00f3n de la Calidad (21 CFR 820) incorpora por referencia <strong>la norma ISO 13485:2016<\/strong>. Un sistema conforme a la norma ISO 13485 es una base s\u00f3lida, pero siguen aplic\u00e1ndose los requisitos espec\u00edficos de la FDA.<\/p><\/div><\/details><\/div>\n<\/div>\n<script type=\"application\/ld+json\">{\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Who regulates medical devices and cosmetics in the U.S.?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Both are regulated by the FDA (U.S. Food and Drug Administration) under the Federal Food, Drug, and Cosmetic Act. 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