{"id":4821,"date":"2025-06-01T10:00:00","date_gmt":"2025-06-01T13:00:00","guid":{"rendered":"https:\/\/sobelconsult.com\/suporte-a-assuntos-regulatorios-eua\/"},"modified":"2026-02-02T15:12:01","modified_gmt":"2026-02-02T18:12:01","slug":"consultoria-fda-dispositivos-medicos","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/consultoria-fda-dispositivos-medicos\/","title":{"rendered":"Suporte a assuntos regulat\u00f3rios - EUA"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"4821\" class=\"elementor elementor-4821 elementor-1765\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2c8e4a5 e-flex e-con-boxed e-con e-parent\" data-id=\"2c8e4a5\" 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-3fe8293 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"3fe8293\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" 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\">Consultoria FDA: Dispositivos M\u00e9dicos\u200b<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8d4d993 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"8d4d993\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" 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\":\"Entering the U.S. medical device market requires precision, strategy, and full alignment with FDA expectations. From classification to submission, Sobel supports manufacturers at every stage of the FDA process \u2014 transforming complex requirements into a clear, efficient, and compliant pathway to approval.\"}]\" data-inline-monday=\"true\">Para entrar no mercado de dispositivos m\u00e9dicos dos Estados Unidos, voc\u00ea precisa estrat\u00e9gia e alinhamento total com as expectativas da FDA. Da classifica\u00e7\u00e3o \u00e0 submiss\u00e3o, a Sobel d\u00e1 suporte aos fabricantes em todas as etapas do processo, com uma consultoria FDA para dispositivos m\u00e9dicos\u200b que transforma requisitos complexos em um caminho claro, eficiente e direcionado para a aprova\u00e7\u00e3o. <\/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-3915b31 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"3915b31\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" 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=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6NzM0NSwidG9nZ2xlIjpmYWxzZX0%3D\">\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\">Tenha suporte especializado<\/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-f19cf34 e-flex e-con-boxed e-con e-parent\" data-id=\"f19cf34\" 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-ce217ea e-con-full e-flex e-con e-child\" data-id=\"ce217ea\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-5fef94c e-con-full e-transform e-flex e-con e-child\" data-id=\"5fef94c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation_mobile&quot;:&quot;fadeIn&quot;,&quot;_transform_translateX_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:96,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:-109,&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_translateY_effect&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;:[]}}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4f6c1db elementor-widget elementor-widget-heading\" data-id=\"4f6c1db\" 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\">Para quem?<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-506ff08 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"506ff08\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-280d786 elementor-align-end elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"280d786\" 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<span class=\"elementor-icon-list-text\">Empresas que preparam, atualizam ou revisam os envios da FDA (510(k), PMA, De Novo, etc.)<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Fabricantes internacionais entrando no mercado 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<span class=\"elementor-icon-list-text\">Equipes de Assuntos Regulat\u00f3rios e Qualidade que precisam de suporte estruturado e cont\u00ednuo<\/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<span class=\"elementor-icon-list-text\">Startups que buscam clareza sobre a classifica\u00e7\u00e3o dos dispositivos e as obriga\u00e7\u00f5es regulat\u00f3rias<\/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<span class=\"elementor-icon-list-text\">Organiza\u00e7\u00f5es que necessitam de consultoria FDA para dispositivos m\u00e9dicos,\u200b para alcan\u00e7ar a conformidade nas suas submiss\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<\/div>\n\t\t<div class=\"elementor-element elementor-element-b3f5459 e-con-full e-flex e-con e-child\" data-id=\"b3f5459\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation_mobile&quot;:&quot;fadeIn&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2aefb96 elementor-widget elementor-widget-image\" data-id=\"2aefb96\" 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=\"755\" height=\"1024\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-755x1024.png\" class=\"attachment-large size-large wp-image-18566\" alt=\"A portable vital signs monitor sits on a table. Office supplies are also on the table. It looks like a doctor&#039;s office.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-755x1024.png 755w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-221x300.png 221w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-768x1041.png 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services.png 1011w\" sizes=\"(max-width: 755px) 100vw, 755px\" \/>\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e53fc74 e-flex e-con-boxed e-con e-parent\" data-id=\"e53fc74\" 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-884d760 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"884d760\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" 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\":\"With deep experience in FDA processes and global regulatory frameworks, Sobel provides the level of technical and strategic support that companies need to access the U.S. market successfully. \"}]\" data-inline-monday=\"true\">Com profunda experi\u00eancia em processos da FDA e do mundo, a Sobel oferece o n\u00edvel de suporte t\u00e9cnico e estrat\u00e9gico de que as empresas precisam para acessar o mercado dos Estados Unidos com sucesso. <\/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-77a6363 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"77a6363\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" 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=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6NzM0NSwidG9nZ2xlIjpmYWxzZX0%3D\">\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\">Obtenha suporte!<\/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-6a1bbcf e-flex e-con-boxed e-con e-parent\" data-id=\"6a1bbcf\" 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-b771077 elementor-widget-mobile__width-inherit elementor-widget elementor-widget-image\" data-id=\"b771077\" 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=\"1259\" height=\"275\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue.png\" class=\"attachment-full size-full wp-image-18572\" alt=\"Vector rectangle blue\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue.png 1259w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-300x66.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-1024x224.png 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-768x168.png 768w\" sizes=\"(max-width: 1259px) 100vw, 1259px\" \/>\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-c9914c2 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"c9914c2\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" 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 voc\u00ea precisa desse servi\u00e7o?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d7a5d75 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"d7a5d75\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-e64a01f e-con-full e-flex e-con e-child\" data-id=\"e64a01f\" 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-ee20a3b elementor-widget elementor-widget-text-editor\" data-id=\"ee20a3b\" 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\":\"FDA compliance is a legal requirement, and misunderstanding these obligations can lead to project stoppages, rejections, or enforcement actions.\"}]\" data-inline-monday=\"true\">A conformidade com a FDA \u00e9 um requisito legal, e n\u00e3o atender certas obriga\u00e7\u00f5es pode levar \u00e0 interrup\u00e7\u00e3o de projetos, a\u00e7\u00f5es de fiscaliza\u00e7\u00e3o ou proibi\u00e7\u00f5es de vendas.<\/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-1f8f9a2 e-con-full e-flex e-con e-child\" data-id=\"1f8f9a2\" 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-2f5373b elementor-widget elementor-widget-text-editor\" data-id=\"2f5373b\" 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 regulatory guidance helps you prepare submissions and documentation that meet FDA expectations without unnecessary rework or delays.\"}]\" data-inline-monday=\"true\">A orienta\u00e7\u00e3o regulat\u00f3ria especializada ajuda voc\u00ea a preparar submiss\u00f5es e documentos que atendam \u00e0s expectativas da FDA, sem retrabalho ou atrasos desnecess\u00e1rios.<\/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-4ac5acf e-con-full e-flex e-con e-child\" data-id=\"4ac5acf\" 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-9c5d53f elementor-widget elementor-widget-text-editor\" data-id=\"9c5d53f\" 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\":\"With expert support, your team strengthens decision-making, reduces regulatory risk, and moves through each FDA step with greater clarity and confidence.\"}]\" data-inline-monday=\"true\">Com o suporte de especialistas, sua equipe fortalece a tomada de decis\u00f5es, reduz os riscos regulat\u00f3rios e avan\u00e7a em cada etapa da FDA com mais clareza e confian\u00e7a.<\/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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5f1b766 e-flex e-con-boxed e-con e-parent\" data-id=\"5f1b766\" 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-fd2938a e-con-full e-flex e-con e-child\" data-id=\"fd2938a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-20ce0b0 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"20ce0b0\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" 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\">Consultoria regulat\u00f3ria em dispositivos m\u00e9dicos para um processo seguro de submiss\u00e3o \u00e0 FDA<\/h3>\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-7af3814 e-con-full e-flex e-con e-child\" data-id=\"7af3814\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e6b60d7 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"e6b60d7\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" 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\":\"Our approach blends technical expertise with practical execution, guiding your company through every regulatory decision. \"}]\" data-inline-monday=\"true\">Nossa abordagem combina conhecimento t\u00e9cnico com execu\u00e7\u00e3o pr\u00e1tica, orientando sua empresa em todas as decis\u00f5es regulat\u00f3rias. <\/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<div class=\"elementor-element elementor-element-9f7dd57 e-flex e-con-boxed e-con e-parent\" data-id=\"9f7dd57\" 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-c78d253 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"c78d253\" 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 Sobel oferece uma estrutura completa de consultoria FDA para dispositivos m\u00e9dicos\u200b, que se adapta \u00e0s metas da sua empresa e \u00e0s exig\u00eancias do mercado.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2c226ee elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"2c226ee\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ucaddon_horizontal_timeline.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\n<!-- start Horizontal Timeline -->\n\t\t<link id='font-awesome-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/font-awesome6\/fontawesome-all.min.css' type='text\/css' rel='stylesheet' >\n\t\t<link id='font-awesome-4-shim-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/font-awesome6\/fontawesome-v4-shims.min.css' type='text\/css' rel='stylesheet' >\n\t\t<link id='owl-carousel-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/owl-carousel-new\/assets\/owl.carousel.css' type='text\/css' rel='stylesheet' >\n\n<style>\/* widget: Horizontal Timeline *\/\n\n#uc_horizontal_timeline_elementor_2c226ee *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_2c226ee .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_2c226ee .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_2c226ee  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_2c226ee  .carousel-nav button i{\n  position: absolute;\n     top: 50%;\n  left: 50%;\n  transform: translate(-50%, -50%);\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_2c226ee .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-bullet i, #uc_horizontal_timeline_elementor_2c226ee .ue-item-bullet svg{\n  position: absolute;\n  top: 50%;\n  left: 50%;\n  transform: translate(-50%, -50%); \n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-carousel-item-holder{\n  display: flex;\n  flex-direction: column;\n  align-items: stretch;\n  height:100%;\n}\n\n<\/style>\n\n<div class=\"ue-horizontal-timeline\" id=\"uc_horizontal_timeline_elementor_2c226ee\">\n     <div class=\"carousel-nav\">\n            <button class=\"carousel-prev\" aria-label=\"Previous\">\n                <i class=' ti-arrow-circle-left'><\/i>\n            <\/button>\n            <button class=\"carousel-next\" aria-label=\"Next\">\n                <i class=' ti-arrow-circle-right'><\/i>\n            <\/button>\n        <\/div>\n    <div class=\"owl-carousel owl-theme uc-items-wrapper item-horizontal-timeline  \" id=\"uc_horizontal_timeline_elementor_2c226ee\" data-custom-sethtml=\"true\"  >\n     \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-58fbbfd\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Escolha seu servi\u00e7o<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Selecione o servi\u00e7o regulat\u00f3rio da FDA de que voc\u00ea precisa. Se n\u00e3o tiver certeza, n\u00f3s o ajudaremos a identificar o caminho certo para o seu dispositivo.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-5ca2a2a\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Forne\u00e7a a documenta\u00e7\u00e3o<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">A Sobel solicita todos os documentos necess\u00e1rios para que o processo regulat\u00f3rio possa avan\u00e7ar com efici\u00eancia e sem atrasos.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-9cdd855\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Acompanhe seu projeto<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Executamos o trabalho enquanto voc\u00ea acompanha cada etapa em tempo real por meio de nossa plataforma de projetos on-line.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n\n  <\/div>\n<\/div>\n<!-- end Horizontal Timeline -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5df4616 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"5df4616\" 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=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6NzM0NSwidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Comece agora!<\/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-897abdc animated-slow e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"897abdc\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c090ee2 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"c090ee2\" 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\">Qual servi\u00e7o se aplica ao seu dispositivo m\u00e9dico?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ad2199c elementor-widget elementor-widget-text-editor\" data-id=\"ad2199c\" 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\":\"FDA regulations require a robust, evidence-based approach to safety, effectiveness, and documentation. You can choose from the following options, depending on your device\u2019s needs and stage of development:\"}]\" data-inline-monday=\"true\">As normas da FDA exigem uma abordagem robusta e baseada em evid\u00eancias para seguran\u00e7a, efic\u00e1cia e documenta\u00e7\u00e3o. Voc\u00ea pode escolher entre as seguintes op\u00e7\u00f5es, dependendo das necessidades do seu dispositivo e do est\u00e1gio de desenvolvimento: <\/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-18e2e92 elementor-arrows-position-outside elementor-pagination-type-bullets elementor-pagination-position-outside elementor-widget elementor-widget-n-carousel\" data-id=\"18e2e92\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;carousel_items&quot;:[{&quot;slide_title&quot;:&quot;Slide #1&quot;,&quot;_id&quot;:&quot;5e096ea&quot;},{&quot;slide_title&quot;:&quot;Slide #2&quot;,&quot;_id&quot;:&quot;6c6581a&quot;},{&quot;slide_title&quot;:&quot;Slide #3&quot;,&quot;_id&quot;:&quot;1d7e525&quot;},{&quot;_id&quot;:&quot;c8e3172&quot;,&quot;slide_title&quot;:&quot;Slide #4&quot;},{&quot;slide_title&quot;:&quot;Slide #5&quot;,&quot;_id&quot;:&quot;8e6060c&quot;},{&quot;slide_title&quot;:&quot;Slide #5&quot;,&quot;_id&quot;:&quot;a38a454&quot;},{&quot;slide_title&quot;:&quot;Slide #5&quot;,&quot;_id&quot;:&quot;3906af6&quot;},{&quot;slide_title&quot;:&quot;Slide #5&quot;,&quot;_id&quot;:&quot;2bd43f9&quot;},{&quot;slide_title&quot;:&quot;Slide #5&quot;,&quot;_id&quot;:&quot;24b3e5a&quot;}],&quot;slides_to_show_tablet&quot;:&quot;2&quot;,&quot;slides_to_show_mobile&quot;:&quot;1&quot;,&quot;autoplay&quot;:&quot;yes&quot;,&quot;autoplay_speed&quot;:5000,&quot;pause_on_hover&quot;:&quot;yes&quot;,&quot;pause_on_interaction&quot;:&quot;yes&quot;,&quot;infinite&quot;:&quot;yes&quot;,&quot;speed&quot;:500,&quot;offset_sides&quot;:&quot;none&quot;,&quot;arrows&quot;:&quot;yes&quot;,&quot;pagination&quot;:&quot;bullets&quot;,&quot;image_spacing_custom&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&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=\"nested-carousel.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-carousel swiper\" role=\"region\" aria-roledescription=\"carousel\" aria-label=\"Carousel\" dir=\"ltr\">\n\t\t\t<div class=\"swiper-wrapper\" aria-live=\"off\">\n\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"1\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"1 de 9\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-27e6060 e-flex e-con-boxed e-con e-child\" data-id=\"27e6060\" 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-d9d2367 e-con-full e-flex e-con e-child\" data-id=\"d9d2367\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-60ec7e8 elementor-widget elementor-widget-heading\" data-id=\"60ec7e8\" 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\">Notifica\u00e7\u00e3o pr\u00e9-mercado 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-aaaaca2 elementor-widget elementor-widget-text-editor\" data-id=\"aaaaca2\" 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\":\"Recommended for manufacturers who need to demonstrate substantial equivalence to a predicate device. This pathway includes classification support, predicate selection, gap analysis, submission preparation, and responses to FDA review comments.\"}]\" data-inline-monday=\"true\">Recomendado para fabricantes que precisam demonstrar equival\u00eancia substancial a um dispositivo predicado. Essa op\u00e7\u00e3o inclui suporte de classifica\u00e7\u00e3o, sele\u00e7\u00e3o de predicados, an\u00e1lise de lacunas, prepara\u00e7\u00e3o de submiss\u00e3o e respostas aos coment\u00e1rios de revis\u00e3o 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\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"2\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"2 de 9\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-efc387a e-flex e-con-boxed e-con e-child\" data-id=\"efc387a\" 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-83a6ab6 e-con-full e-flex e-con e-child\" data-id=\"83a6ab6\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bf03f94 elementor-widget elementor-widget-heading\" data-id=\"bf03f94\" 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\">Registro e listagem de dispositivos FURLS<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b0d6811 elementor-widget elementor-widget-text-editor\" data-id=\"b0d6811\" 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\":\"For manufacturers entering the U.S. market or introducing new devices. Sobel manages the registration and listing process in the FURLS database so your products can be legally commercialized in the U.S.\"}]\" data-inline-monday=\"true\">Ideal para fabricantes que est\u00e3o entrando no mercado dos EUA ou introduzindo novos dispositivos. A Sobel gerencia o processo de registro e listagem no banco de dados FURLS para que seus produtos possam ser comercializados legalmente no pa\u00eds. <\/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\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"3\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"3 de 9\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e257e45 e-flex e-con-boxed e-con e-child\" data-id=\"e257e45\" 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-2bf73b6 e-con-full e-flex e-con e-child\" data-id=\"2bf73b6\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ada69d5 elementor-widget elementor-widget-heading\" data-id=\"ada69d5\" 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\">Registro de instala\u00e7\u00f5es FURLS<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0a0e691 elementor-widget elementor-widget-text-editor\" data-id=\"0a0e691\" 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\":\"Required for foreign establishments manufacturing medical devices for the U.S. market. Sobel creates and registers your facility in the FURLS system, ensuring it complies with FDA establishment registration rules.\"}]\" data-inline-monday=\"true\">Obrigat\u00f3rio para estabelecimentos estrangeiros que fabricam dispositivos m\u00e9dicos para o mercado dos EUA. A Sobel realiza o cadastro e o registro do seu estabelecimento no sistema FURLS da FDA, garantindo conformidade com as regras de registro de estabelecimentos. <\/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\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"4\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"4 de 9\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-66c119b e-flex e-con-boxed e-con e-child\" data-id=\"66c119b\" 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-a56d2ab e-con-full e-flex e-con e-child\" data-id=\"a56d2ab\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fb961b8 elementor-widget elementor-widget-heading\" data-id=\"fb961b8\" 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\">Manuten\u00e7\u00e3o anual do FURLS para dispositivos e instala\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-17c4a09 elementor-widget elementor-widget-text-editor\" data-id=\"17c4a09\" 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\":\"Ideal for companies that already sell medical devices in the U.S. and must keep their establishment and device listings active. Ensures ongoing compliance with annual FDA registration obligations.\"}]\" data-inline-monday=\"true\">Ideal para empresas que j\u00e1 vendem dispositivos m\u00e9dicos nos EUA e precisam manter ativos seus registros de instala\u00e7\u00f5es e produtos. Garante a conformidade cont\u00ednua com as obriga\u00e7\u00f5es anuais de registro na 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\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"5\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"5 de 9\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4ff194e e-flex e-con-boxed e-con e-child\" data-id=\"4ff194e\" 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-51f1a55 e-con-full e-flex e-con e-child\" data-id=\"51f1a55\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c279c5b elementor-widget elementor-widget-heading\" data-id=\"c279c5b\" 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\">Se\u00e7\u00e3o 513(g)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c561daa elementor-widget elementor-widget-text-editor\" data-id=\"c561daa\" 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\":\"Recommended when manufacturers need official clarity from the FDA regarding device classification or applicable regulatory requirements. Sobel prepares and submits the 513(g) request, helping you define the correct regulatory pathway early on.\"}]\" data-inline-monday=\"true\">Recomendado quando os fabricantes precisam de esclarecimentos da FDA com rela\u00e7\u00e3o \u00e0 classifica\u00e7\u00e3o do dispositivo ou aos requisitos regulat\u00f3rios aplic\u00e1veis. A Sobel prepara e envia a solicita\u00e7\u00e3o 513(g), ajudando voc\u00ea a definir o caminho regulat\u00f3rio correto desde o in\u00edcio. <\/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\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"6\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"6 de 9\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-418de73 e-flex e-con-boxed e-con e-child\" data-id=\"418de73\" 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-584356c e-con-full e-flex e-con e-child\" data-id=\"584356c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6dbb74e elementor-widget elementor-widget-heading\" data-id=\"6dbb74e\" 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\">Certifica\u00e7\u00e3o MDUFA para pequenas empresas<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e48ca1a elementor-widget elementor-widget-text-editor\" data-id=\"e48ca1a\" 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\":\"Essential for companies seeking reduced FDA user fees. Sobel prepares and submits the documentation required for certification, helping qualified manufacturers significantly decrease FDA submission costs.\"}]\" data-inline-monday=\"true\">Essencial para empresas que buscam reduzir as taxas de utiliza\u00e7\u00e3o da FDA. Preparamos e submetemos a documenta\u00e7\u00e3o necess\u00e1ria para a certifica\u00e7\u00e3o, ajudando os fabricantes qualificados a reduzir significativamente os custos de envio \u00e0 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\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"7\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"7 de 9\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-09e981a e-flex e-con-boxed e-con e-child\" data-id=\"09e981a\" 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-ac157a8 e-con-full e-flex e-con e-child\" data-id=\"ac157a8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-cf35f4d elementor-widget elementor-widget-heading\" data-id=\"cf35f4d\" 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\">GUDID (Registro UDI)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-290a7c9 elementor-widget elementor-widget-text-editor\" data-id=\"290a7c9\" 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\":\"Required for devices subject to FDA UDI rules. Sobel creates your GUDID account and enters all UDI and label information so your device is properly registered in the FDA database.\"}]\" data-inline-monday=\"true\">Necess\u00e1rio para dispositivos sujeitos \u00e0s regras de UDI da FDA. A Sobel cria sua conta GUDID e insere todas as informa\u00e7\u00f5es de UDI e r\u00f3tulo para que seu dispositivo seja registrado corretamente no banco de dados da ag\u00eancia. <\/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\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"8\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"8 de 9\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2f1450a e-flex e-con-boxed e-con e-child\" data-id=\"2f1450a\" 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-d008795 e-con-full e-flex e-con e-child\" data-id=\"d008795\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a4b78eb elementor-widget elementor-widget-heading\" data-id=\"a4b78eb\" 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\">Avalia\u00e7\u00e3o de r\u00f3tulos<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-37f43a9 elementor-widget elementor-widget-text-editor\" data-id=\"37f43a9\" 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\":\"Recommended for manufacturers preparing labels for the U.S. market. Sobel verifies compliance, identifies gaps, and provides actionable guidance to correct or update your labeling according to FDA requirements.\"}]\" data-inline-monday=\"true\">Recomendado para fabricantes que preparam r\u00f3tulos dos produtos para o mercado norte americano. A Sobel verifica a conformidade, identifica poss\u00edveis falhas e fornece orienta\u00e7\u00f5es pr\u00e1ticas para voc\u00ea corrigir ou atualizar sua rotulagem de acordo com os requisitos 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\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"9\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"9 de 9\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-bc51486 e-flex e-con-boxed e-con e-child\" data-id=\"bc51486\" 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-157dd80 e-con-full e-flex e-con e-child\" data-id=\"157dd80\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a997f20 elementor-widget elementor-widget-heading\" data-id=\"a997f20\" 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 a Assuntos Regulat\u00f3rios (Consultoria Mensal)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cd6c24e elementor-widget elementor-widget-text-editor\" data-id=\"cd6c24e\" 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\":\"Designed for companies that need ongoing support with FDA-related questions. Provides fast, written regulatory guidance for day-to-day decisions, so your team remains aligned with FDA expectations.\"}]\" data-inline-monday=\"true\">Projetado para empresas que precisam de suporte cont\u00ednuo para quest\u00f5es relacionadas \u00e0 FDA. Fornece orienta\u00e7\u00e3o regulat\u00f3ria r\u00e1pida e por escrito para as decis\u00f5es di\u00e1rias, para que sua equipe permane\u00e7a alinhada com as expectativas da ag\u00eancia. <\/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\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-swiper-button elementor-swiper-button-prev\" role=\"button\" tabindex=\"0\" aria-label=\"Anterior\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-eicon-chevron-left\" viewBox=\"0 0 1000 1000\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M646 125C629 125 613 133 604 142L308 442C296 454 292 471 292 487 292 504 296 521 308 533L604 854C617 867 629 875 646 875 663 875 679 871 692 858 704 846 713 829 713 812 713 796 708 779 692 767L438 487 692 225C700 217 708 204 708 187 708 171 704 154 692 142 675 129 663 125 646 125Z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t\t<div class=\"elementor-swiper-button elementor-swiper-button-next\" role=\"button\" tabindex=\"0\" aria-label=\"Pr\u00f3ximo\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-eicon-chevron-right\" viewBox=\"0 0 1000 1000\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M696 533C708 521 713 504 713 487 713 471 708 454 696 446L400 146C388 133 375 125 354 125 338 125 325 129 313 142 300 154 292 171 292 187 292 204 296 221 308 233L563 492 304 771C292 783 288 800 288 817 288 833 296 850 308 863 321 871 338 875 354 875 371 875 388 867 400 854L696 533Z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t\t\t\t<div class=\"swiper-pagination\"><\/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-0a1174a elementor-widget elementor-widget-text-editor\" data-id=\"0a1174a\" 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\":\"Our medical device regulatory consulting approach bridges knowledge gaps, reduces risk, and accelerates your time-to-market.\"}]\" data-inline-monday=\"true\"><strong>Nossa abordagem de consultoria em regulamenta\u00e7\u00e3o de dispositivos m\u00e9dicos preenche gaps de conhecimento, reduz os riscos e acelera o tempo de entrada no mercado.<\/strong><\/p>\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-9c6e17d e-flex e-con-boxed e-con e-parent\" data-id=\"9c6e17d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-df067c7 e-con-full e-flex e-con e-child\" data-id=\"df067c7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-458ccc0 elementor-widget__width-inherit elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"458ccc0\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9b45320 elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"9b45320\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" 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\">Servi\u00e7os relacionados<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5218ed1 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"5218ed1\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" 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\":\"With Sobel, you eliminate uncertainty and prevent common mistakes that compromise timelines and budgets. You can also have support on these complementary services:\"}]\" data-inline-monday=\"true\">Com a Sobel, voc\u00ea elimina a incerteza e evita erros comuns que comprometem cronogramas e or\u00e7amentos. Voc\u00ea tamb\u00e9m pode contar com esses servi\u00e7os complementares: <\/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-7ff23d6 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"7ff23d6\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-34229c3 e-con-full e-flex e-con e-child\" data-id=\"34229c3\" 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-95e6e5b elementor-widget elementor-widget-heading\" data-id=\"95e6e5b\" 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\">Avalia\u00e7\u00e3o Biol\u00f3gica (BEP, BER)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-996a9c7 elementor-widget elementor-widget-text-editor\" data-id=\"996a9c7\" 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\":{\"background\":\"var(--color-egg_yolk-selected)\"},\"insert\":\"BEP, BER, and toxicological support. Clear, defensible biological evaluation documentation.\"}]\" data-inline-monday=\"true\">BEP, BER e suporte toxicol\u00f3gico. Documenta\u00e7\u00e3o de avalia\u00e7\u00e3o biol\u00f3gica clara e defens\u00e1vel. <\/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-a8ba134 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"a8ba134\" 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\/pt-br\/our-solutions-usa\/relatorio-de-avaliacao-biologica-iso-10993\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Veja mais<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7c1f729 e-con-full e-flex e-con e-child\" data-id=\"7c1f729\" 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-3efdcbd elementor-widget elementor-widget-heading\" data-id=\"3efdcbd\" 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\">Servi\u00e7o de US Agent FDA<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-49e6c81 elementor-widget elementor-widget-text-editor\" data-id=\"49e6c81\" 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<div class=\"elementor-element elementor-element-7d42130 elementor-widget elementor-widget-text-editor\" data-id=\"7d42130\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><div class=\"elementor-element elementor-element-7d42130 elementor-widget elementor-widget-text-editor\" data-id=\"7d42130\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Navigate market access in the U.S.A. with Sobel as your device US Agent.\"}]\" data-inline-monday=\"true\">Tenha acesso ao mercado dos EUA com a Sobel como seu representante local.<\/p><\/div><\/div><\/div><\/div>\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-45c8e66 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"45c8e66\" 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\/pt-br\/our-solutions-usa\/us-agent-fda\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Veja mais<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e62467d e-con-full e-flex e-con e-child\" data-id=\"e62467d\" 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-e757528 elementor-widget elementor-widget-heading\" data-id=\"e757528\" 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 Sistema da Qualidade<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c99a659 elementor-widget elementor-widget-text-editor\" data-id=\"c99a659\" 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\":{\"background\":\"var(--color-bright-green-selected)\"},\"insert\":\"Align your QMS with FDA 21 CFR 820, ISO 13485, and MDSAP in the U.S.A.\"}]\" data-inline-monday=\"true\">Alinhe seu SGQ com o FDA 21 CFR 820, ISO 13485 e MDSAP nos Estados Unidos.<\/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-86776d5 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"86776d5\" 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\/pt-br\/our-solutions-usa\/sistema-da-qualidade-fda\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Veja mais<\/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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1a9afd2 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"1a9afd2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-8012677 e-con-full e-flex e-con e-child\" data-id=\"8012677\" 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-4ce197a e-con-full e-flex e-con e-child\" data-id=\"4ce197a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-89b1268 elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"89b1268\" 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\">Voc\u00ea est\u00e1 pronto para alcan\u00e7ar conformidade com a FDA?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a5f1acc elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"a5f1acc\" 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 oferece uma abordagem abrangente, estrat\u00e9gica e pr\u00e1tica para a consultoria FDA dispositivos m\u00e9dicos\u200b, proporcionando \u00e0 sua empresa a clareza, a confian\u00e7a e a prontid\u00e3o necess\u00e1rias para entrar e ter sucesso no mercado dos EUA.<\/p><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Contact us to start your FDA compliance pathway with confidence.\"}]\" data-inline-monday=\"true\"><strong>Entre em contato e inicie seu processo de conformidade com a FDA de forma segura e estruturada.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-31e2763 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"31e2763\" 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=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6NzM0NSwidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Tenha suporte especializado<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bf3a548 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"bf3a548\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-63caaba elementor-widget__width-inherit elementor-widget elementor-widget-toggle\" data-id=\"63caaba\" 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-1041\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1041\" 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-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/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\">Voc\u00ea ainda tem d\u00favidas? D\u00ea uma olhada em nosso FAQ. <\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1041\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1041\"><p><b>1. Qual \u00e9 a primeira etapa regulat\u00f3ria ao entrar no mercado de dispositivos m\u00e9dicos dos EUA?<\/b><\/p>\n<p>A maioria das empresas come\u00e7a determinando a classifica\u00e7\u00e3o do dispositivo (Classe I, II ou III) e identificando a via regulat\u00f3ria aplic\u00e1vel, como 510(k), De Novo, PMA ou isen\u00e7\u00e3o. Essa etapa define quais atividades de documenta\u00e7\u00e3o, teste e registro ser\u00e3o necess\u00e1rias. <\/p>\n<p><b>2. Como posso saber se meu dispositivo precisa de uma submiss\u00e3o 510(k), De Novo ou PMA?<\/b><\/p>\n<p>O caminho correto depende do uso pretendido do seu dispositivo, do n\u00edvel de risco e da exist\u00eancia de um dispositivo predicado no mercado dos Estados Unidos. A an\u00e1lise de classifica\u00e7\u00e3o e a identifica\u00e7\u00e3o de predicados s\u00e3o etapas iniciais essenciais, e a Sobel ajuda voc\u00ea a avaliar todas as op\u00e7\u00f5es dispon\u00edveis. <\/p>\n<p><b>3. Preciso registrar minha empresa no FDA antes de vender um dispositivo?<\/b><\/p>\n<p>Sim. Todos os fabricantes, inclusive empresas estrangeiras, devem preencher o Registro de Instala\u00e7\u00f5es e a Listagem de Dispositivos por meio do sistema FURLS. Esses registros tamb\u00e9m devem ser renovados anualmente.  <\/p>\n<p><b>4. O que \u00e9 UDI e eu preciso de um registro GUDID?<\/b><\/p>\n<p>A maioria dos dispositivos vendidos nos EUA deve ter um identificador exclusivo de dispositivo (UDI), e as informa\u00e7\u00f5es devem ser inseridas no banco de dados GUDID da FDA. A Sobel cria a sua conta e registra todos os dados necess\u00e1rios do dispositivo, mas o UDI em si deve ser fornecido pelo fabricante. <\/p>\n<p><b>5. A Sobel pode ajudar a determinar quais documentos est\u00e3o faltando para a conformidade com a FDA?<\/b><\/p>\n<p>Sim. A Sobel realiza avalia\u00e7\u00f5es detalhadas de lacunas regulat\u00f3rias para identificar testes ausentes, se\u00e7\u00f5es incompletas ou documenta\u00e7\u00e3o que n\u00e3o atende aos requisitos da FDA. Isso evita o retrabalho e acelera o processo de submiss\u00e3o.  <\/p>\n<p><b>6. O que acontece se a FDA emitir coment\u00e1rios de revis\u00e3o ou solicitar informa\u00e7\u00f5es adicionais?<\/b><\/p>\n<p>A Sobel ajuda voc\u00ea a entender, interpretar e responder aos coment\u00e1rios da FDA. Respostas claras e bem estruturadas s\u00e3o essenciais para evitar que voc\u00ea prolongue o ciclo de revis\u00e3o ou desencadeie rodadas adicionais de perguntas. <\/p>\n<p><b>7. Eu me qualifico para taxas de envio reduzidas no programa MDUFA para pequenas empresas?<\/b><\/p>\n<p>Depende. A certifica\u00e7\u00e3o para pequenas empresas pode reduzir significativamente as taxas da FDA, mas exige documenta\u00e7\u00e3o financeira espec\u00edfica e uma solicita\u00e7\u00e3o formal \u00e0 ag\u00eancia. A Sobel gerencia o processo de envio e comunica\u00e7\u00e3o para essa certifica\u00e7\u00e3o.  <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Consultoria especializada em regulamenta\u00e7\u00e3o de dispositivos m\u00e9dicos para submiss\u00f5es, registro, UDI e conformidade com a FDA.<\/p>\n","protected":false},"author":11,"featured_media":25338,"parent":7775,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-4821","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.3 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Consultoria FDA para Dispositivos M\u00e9dicos\u200b<\/title>\n<meta name=\"description\" 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