{"id":7711,"date":"2025-06-01T10:00:00","date_gmt":"2025-06-01T13:00:00","guid":{"rendered":"https:\/\/sobelconsult.com\/treinamento-em-regulamentacao-de-dispositivos-medicos-nos-eua\/"},"modified":"2026-02-02T15:10:47","modified_gmt":"2026-02-02T18:10:47","slug":"treinamento-assuntos-regulatorios-fda","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/","title":{"rendered":"Treinamento em regulamenta\u00e7\u00e3o de dispositivos m\u00e9dicos nos EUA"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7711\" class=\"elementor elementor-7711 elementor-6791\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-06d8c5f e-flex e-con-boxed e-con e-parent\" data-id=\"06d8c5f\" 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-d6d54b3 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"d6d54b3\" 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\">Treinamento em Assuntos Regulat\u00f3rios FDA<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-91edf08 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"91edf08\" 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\":\"Keep your team aligned with FDA requirements and ISO 14971 risk-management principles through structured, expert-led training. Our Regulatory Affairs training give your organization the clarity and confidence needed to operate compliantly in the U.S. market.\"}]\" data-inline-monday=\"true\">Mantenha a sua equipe alinhada com os requisitos da FDA e os princ\u00edpios da ISO 10993-1 por meio de treinamento estruturado e orientado por especialistas. Nosso treinamento em Assuntos Regulat\u00f3rios oferece \u00e0 sua organiza\u00e7\u00e3o a clareza e a confian\u00e7a necess\u00e1rias para operar em conformidade com o mercado dos EUA. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-98eb39b elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"98eb39b\" 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-3bb56c7 e-flex e-con-boxed e-con e-parent\" data-id=\"3bb56c7\" 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-b2a1062 e-con-full e-flex e-con e-child\" data-id=\"b2a1062\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-dec71ca e-con-full e-transform e-flex e-con e-child\" data-id=\"dec71ca\" 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-b8899fa elementor-widget elementor-widget-heading\" data-id=\"b8899fa\" 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-c12bc14 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"c12bc14\" 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-978059d elementor-align-end elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"978059d\" 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 preparando equipes para submiss\u00f5es \u00e0 FDA ou entrada no mercado dos Estados Unidos.<\/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 regulamenta\u00e7\u00e3o, qualidade, engenharia e fabrica\u00e7\u00e3o que precisam de treinamento atualizado.<\/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 globais atualizando as equipes sobre as recentes mudan\u00e7as regulat\u00f3rias na FDA e nos padr\u00f5es de gerenciamento de riscos.<\/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-212bcae e-con-full e-flex e-con e-child\" data-id=\"212bcae\" 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-99a8285 elementor-widget elementor-widget-image\" data-id=\"99a8285\" 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-8f62ac1 e-flex e-con-boxed e-con e-parent\" data-id=\"8f62ac1\" 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-0c5c773 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"0c5c773\" 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\":\"Build stronger regulatory foundations with expert guidance.\"}]\" data-inline-monday=\"true\">Construa bases regulat\u00f3rias mais s\u00f3lidas com treinamento em assuntos regulat\u00f3rios focados em 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-4f72ad9 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"4f72ad9\" 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-62f7280 e-flex e-con-boxed e-con e-parent\" data-id=\"62f7280\" 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-923449b elementor-widget-mobile__width-inherit elementor-widget elementor-widget-image\" data-id=\"923449b\" 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-1d959dd elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"1d959dd\" 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-09ca5b0 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"09ca5b0\" 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-eaafb5f e-con-full e-flex e-con e-child\" data-id=\"eaafb5f\" 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-f5e7c62 elementor-widget elementor-widget-text-editor\" data-id=\"f5e7c62\" 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\":\"Regulatory expectations are increasing, and your team needs consistent, accurate guidance to interpret FDA and ISO 10993-1 and ISO 14971 requirements.\"}]\" data-inline-monday=\"true\">As expectativas regulat\u00f3rias est\u00e3o aumentando, e a sua equipe pode contar com orienta\u00e7\u00e3o consistente e precisa para interpretar os requisitos da FDA e da ISO 10993-1.<\/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-4417f6b e-con-full e-flex e-con e-child\" data-id=\"4417f6b\" 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-673759a elementor-widget elementor-widget-text-editor\" data-id=\"673759a\" 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\":\"Effective risk management depends on professionals who understand how to identify hazards, evaluate risks, and document decisions correctly.\"}]\" data-inline-monday=\"true\">Um s\u00f3lido entendimento da ISO 10993-1 \u00e9 fundamental para a realiza\u00e7\u00e3o de avalia\u00e7\u00f5es biol\u00f3gicas que atendam \u00e0s expectativas regulat\u00f3rias e apoiem a seguran\u00e7a do produto.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-34d8ca2 e-con-full e-flex e-con e-child\" data-id=\"34d8ca2\" 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-6ec1787 elementor-widget elementor-widget-text-editor\" data-id=\"6ec1787\" 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\":\"Well-trained teams prevent nonconformities, reduce delays, and strengthen compliance across every stage of your device lifecycle.\"}]\" data-inline-monday=\"true\">Equipes bem treinadas evitam n\u00e3o conformidades, reduzem atrasos e fortalecem o atendimento aos requisitos regulat\u00f3rios em todas as etapas do ciclo de vida do dispositivo.<\/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-ec684df e-flex e-con-boxed e-con e-parent\" data-id=\"ec684df\" 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-2fc8bf7 e-con-full e-flex e-con e-child\" data-id=\"2fc8bf7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-920594a elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"920594a\" 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\">Treinamento projetado para um impacto regulat\u00f3rio real<\/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-231e2b3 e-con-full e-flex e-con e-child\" data-id=\"231e2b3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1dcbfd5 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"1dcbfd5\" 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>Nossos programas de treinamento assuntos regulat\u00f3rios FDA s\u00e3o projetados para aplica\u00e7\u00e3o pr\u00e1tica, com exemplos do mundo real, explica\u00e7\u00f5es claras e discuss\u00f5es interativas. <\/p><p><strong>Oferecidas on-line ou na sua empresa, cada sess\u00e3o prepara os participantes para aplicar os conceitos regulat\u00f3rios diretamente \u00e0s suas atividades di\u00e1rias, melhorando a conformidade e os resultados dos produtos.<\/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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-32c61c8 e-flex e-con-boxed e-con e-parent\" data-id=\"32c61c8\" 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-e0eec77 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"e0eec77\" 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\">Uma abordagem estruturada para o treinamento em ISO 10993-1 e assuntos regulat\u00f3rios:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d590320 elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"d590320\" 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_d590320 *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_d590320{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_d590320 .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_d590320 .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_d590320 .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_d590320 .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_d590320 .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_d590320 .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_d590320 .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_d590320 .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_d590320  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_d590320  .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_d590320 .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_d590320 .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_d590320 .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_d590320 .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_d590320 .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_d590320 .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_d590320 .ue-item-bullet i, #uc_horizontal_timeline_elementor_d590320 .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_d590320 .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_d590320 .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_d590320 .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_d590320 .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_d590320 .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_d590320 .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_d590320 .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_d590320 .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_d590320 .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_d590320\">\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_d590320\" 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=\"#\" >Selecione seu treinamento<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Escolha um treinamento em assuntos regulat\u00f3rios FDA, dependendo das necessidades da sua equipe.<\/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=\"#\" >Defina o formato<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Escolha o treinamento remoto via MS Teams ou agende uma sess\u00e3o no local ministrada por um profissional experiente em regulamenta\u00e7\u00e3o.<\/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=\"#\" >Conhecimento aplicado<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Aprenda por meio de exemplos reais, discuss\u00f5es de cen\u00e1rios e explica\u00e7\u00f5es pr\u00e1ticas que conectam os requisitos ao trabalho regulat\u00f3rio cotidiano.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-e43fc00\">\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=\"#\" >Certificado de conclus\u00e3o<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Cada participante recebe um certificado de treinamento oficial na conclus\u00e3o do curso.<\/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-bbfbd31 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"bbfbd31\" 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-065881c animated-slow e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"065881c\" 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-ada1b64 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"ada1b64\" 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\">Nossos programas de treinamento<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d33310f elementor-widget elementor-widget-text-editor\" data-id=\"d33310f\" 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-led sessions delivered online or on-site, Sobel Consultancy provides a clear pathway to understanding FDA expectations, mastering ISO 14971 risk management, and strengthening internal processes that support safe, compliant products.\"}]\" data-inline-monday=\"true\">Com sess\u00f5es conduzidas por especialistas e ministradas on-line ou no local, a Sobel oferece um caminho claro para que voc\u00ea entenda as expectativas da FDA, domine a ISO 10993-1 e fortale\u00e7a os processos internos que d\u00e3o suporte a produtos seguros e em conformidade.<\/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-b2d2cd9 e-flex e-con-boxed e-con e-child\" data-id=\"b2d2cd9\" 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-b0bfbfa e-con-full e-flex e-con e-child\" data-id=\"b0bfbfa\" 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-5cdf0ab elementor-widget elementor-widget-heading\" data-id=\"5cdf0ab\" 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\">Treinamento em 21 CFR 820 (Regulamento do Sistema de Qualidade da FDA - SGQ)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0f2287c elementor-widget elementor-widget-text-editor\" data-id=\"0f2287c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"A comprehensive training focused on FDA\u2019s 21 CFR 820 requirements, including quality management expectations, inspection readiness, and practical compliance applications. This 6-hour training equips teams to understand QSR structure, responsibilities, documentation needs, and how FDA assesses quality systems. \"}]\" data-inline-monday=\"true\">Um treinamento abrangente focado nos requisitos do 21 CFR 820 da FDA, incluindo expectativas de gerenciamento de qualidade, prontid\u00e3o para inspe\u00e7\u00e3o e aplica\u00e7\u00f5es pr\u00e1ticas de conformidade. Esse treinamento de 6 horas prepara as equipes para entender a estrutura de SGQ, as responsabilidades, as necessidades de documenta\u00e7\u00e3o e como a FDA avalia os sistemas de qualidade.  <\/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-86a6395 e-con-full e-flex e-con e-child\" data-id=\"86a6395\" 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-bd71801 elementor-widget elementor-widget-heading\" data-id=\"bd71801\" 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\">Treinamento em ISO 10993-1<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-45b5ccd elementor-widget elementor-widget-text-editor\" data-id=\"45b5ccd\" 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\":\"ISO 10993 sets the framework for biological evaluation and biocompatibility assessment of medical devices. This training helps teams stay aligned with current requirements, structure biological evaluation plans, and address common issues that may impact regulatory timelines.\"}]\" data-inline-monday=\"true\">A ISO 10993-1:2025 define a estrutura para a avalia\u00e7\u00e3o biol\u00f3gica e a avalia\u00e7\u00e3o da biocompatibilidade de dispositivos m\u00e9dicos. Esse treinamento ajuda as equipes a se manterem alinhadas com os requisitos atuais, estruturar planos de avalia\u00e7\u00e3o biol\u00f3gica e abordar problemas comuns que podem afetar os prazos regulamentares. <\/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<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-37bc441 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"37bc441\" 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-4645700 e-con-full e-flex e-con e-child\" data-id=\"4645700\" 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-c30d1b6 e-con-full e-flex e-con e-child\" data-id=\"c30d1b6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4ef4b19 elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"4ef4b19\" 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\">Treinamento em assuntos regulat\u00f3rios FDA conduzido por especialistas<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d95db2a elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"d95db2a\" 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>Investir em treinamento profissional e estruturado \u00e9 uma das maneiras mais eficazes de desenvolver capacidades regulat\u00f3rias internas, evitar n\u00e3o conformidades e acelerar o desenvolvimento bem-sucedido de produtos.<\/p><p><strong>Com a Sobel, sua equipe ganha clareza, confian\u00e7a e uma s\u00f3lida compreens\u00e3o dos requisitos da FDA e da ISO 10993-1, para produzir dispositivos mais seguros e ter melhores resultados de conformidade.<\/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-228fcf6 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"228fcf6\" 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<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-34be1a9 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"34be1a9\" 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-2d8f135 elementor-widget__width-inherit elementor-widget elementor-widget-toggle\" data-id=\"2d8f135\" 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-4771\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-4771\" 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-4771\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-4771\"><p><b>1. Quem deve participar desses programas de treinamento?<\/b><\/p>\n<p>Esses treinamentos s\u00e3o ideais para equipes de assuntos regulat\u00f3rios, profissionais de qualidade, engenheiros de P&amp;D, especialistas em fabrica\u00e7\u00e3o e qualquer pessoa envolvida em gerenciamento de riscos, documenta\u00e7\u00e3o ou submiss\u00f5es \u00e0 FDA.<\/p>\n<p><b>2. Os treinamentos abrangem aplica\u00e7\u00f5es pr\u00e1ticas ou apenas teoria?<\/b><\/p>\n<p>As sess\u00f5es combinam ambos. Os participantes recebem conte\u00fado t\u00e9cnico estruturado com o apoio de exemplos do mundo real, discuss\u00f5es de cen\u00e1rios e explica\u00e7\u00f5es pr\u00e1ticas para aplicar os requisitos no trabalho di\u00e1rio. <\/p>\n<p><b>3. Por que o treinamento em 21 CFR 820 \u00e9 importante para a minha empresa?<\/b><\/p>\n<p>O treinamento em 21 CFR 820 prepara a sua equipe para atender \u00e0s expectativas do sistema de qualidade da FDA, entender os requisitos de documenta\u00e7\u00e3o e evitar problemas comuns de conformidade. Ele ajuda a estabelecer uma base s\u00f3lida de SGQ e melhora a prontid\u00e3o para inspe\u00e7\u00f5es e entrada no mercado dos Estados Unidos. <\/p>\n<p><b>4. O treinamento pode ser realizado on-line?<\/b><\/p>\n<p>Sim. Todos os programas podem ser ministrados remotamente por meio do Microsoft Teams ou no local em suas instala\u00e7\u00f5es, dependendo da sua prefer\u00eancia ou programa\u00e7\u00e3o. Cada participante recebe um certificado oficial de conclus\u00e3o ao final do treinamento.  <\/p>\n<p><b>5. O conte\u00fado pode ser personalizado de acordo com a empresa ou o tipo de dispositivo?<\/b><\/p>\n<p>Sim. Embora os m\u00f3dulos principais sigam os requisitos da FDA e da ISO, os exemplos e as discuss\u00f5es podem ser adaptados ao contexto regulat\u00f3rio e \u00e0 categoria de dispositivo da sua empresa. <\/p>\n<p><b>6. Como podemos agendar o treinamento?<\/b><\/p>\n<p>Quando voc\u00ea entra em contato com a nossa equipe, alinhamos o escopo do treinamento, selecionamos o formato (on-line ou presencial), definimos os participantes e marcamos a data que melhor se adapta \u00e0 disponibilidade da sua equipe.<\/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>Treinamento em assuntos regulat\u00f3rios conduzido por especialistas que fortalece o gerenciamento de riscos, a conformidade e o desempenho da equipe.<\/p>\n","protected":false},"author":11,"featured_media":7246,"parent":7775,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-7711","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>Treinamento em Assuntos Regulat\u00f3rios FDA | Dispositivos M\u00e9dicos<\/title>\n<meta name=\"description\" content=\"Treinamento em assuntos regulat\u00f3rios conduzido por especialistas que fortalece o gerenciamento de riscos, a conformidade e o desempenho da equipe. 21 CFR 820 e ISO 10993-1.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Treinamento em regulamenta\u00e7\u00e3o de dispositivos m\u00e9dicos nos EUA\" \/>\n<meta property=\"og:description\" content=\"Treinamento em assuntos regulat\u00f3rios conduzido por especialistas que fortalece o gerenciamento de riscos, a conformidade e o desempenho da equipe. 21 CFR 820 e ISO 10993-1.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/\" \/>\n<meta property=\"og:site_name\" content=\"Sobel\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-02T18:10:47+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-affairs-training.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"657\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. tempo de leitura\" \/>\n\t<meta name=\"twitter:data1\" content=\"5 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/\",\"url\":\"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/\",\"name\":\"Treinamento em Assuntos Regulat\u00f3rios FDA | Dispositivos M\u00e9dicos\",\"isPartOf\":{\"@id\":\"https:\/\/sobelconsult.com\/pt-br\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-affairs-training.webp\",\"datePublished\":\"2025-06-01T13:00:00+00:00\",\"dateModified\":\"2026-02-02T18:10:47+00:00\",\"description\":\"Treinamento em assuntos regulat\u00f3rios conduzido por especialistas que fortalece o gerenciamento de riscos, a conformidade e o desempenho da equipe. 21 CFR 820 e ISO 10993-1.\",\"breadcrumb\":{\"@id\":\"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/#breadcrumb\"},\"inLanguage\":\"pt-BR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"pt-BR\",\"@id\":\"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/#primaryimage\",\"url\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-affairs-training.webp\",\"contentUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-affairs-training.webp\",\"width\":1000,\"height\":657,\"caption\":\"An online training course about regulatory affairs FDA\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/sobelconsult.com\/pt-br\/home\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Nossas solu\u00e7\u00f5es EUA\",\"item\":\"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Treinamento em regulamenta\u00e7\u00e3o de dispositivos m\u00e9dicos nos EUA\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/sobelconsult.com\/pt-br\/#website\",\"url\":\"https:\/\/sobelconsult.com\/pt-br\/\",\"name\":\"Sobel\",\"description\":\"Regulatory Consultancy\",\"publisher\":{\"@id\":\"https:\/\/sobelconsult.com\/pt-br\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/sobelconsult.com\/pt-br\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"pt-BR\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/sobelconsult.com\/pt-br\/#organization\",\"name\":\"Sobel\",\"url\":\"https:\/\/sobelconsult.com\/pt-br\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"pt-BR\",\"@id\":\"https:\/\/sobelconsult.com\/pt-br\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png\",\"contentUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png\",\"width\":741,\"height\":290,\"caption\":\"Sobel\"},\"image\":{\"@id\":\"https:\/\/sobelconsult.com\/pt-br\/#\/schema\/logo\/image\/\"}}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Treinamento em Assuntos Regulat\u00f3rios FDA | Dispositivos M\u00e9dicos","description":"Treinamento em assuntos regulat\u00f3rios conduzido por especialistas que fortalece o gerenciamento de riscos, a conformidade e o desempenho da equipe. 21 CFR 820 e ISO 10993-1.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/","og_locale":"pt_BR","og_type":"article","og_title":"Treinamento em regulamenta\u00e7\u00e3o de dispositivos m\u00e9dicos nos EUA","og_description":"Treinamento em assuntos regulat\u00f3rios conduzido por especialistas que fortalece o gerenciamento de riscos, a conformidade e o desempenho da equipe. 21 CFR 820 e ISO 10993-1.","og_url":"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/","og_site_name":"Sobel","article_modified_time":"2026-02-02T18:10:47+00:00","og_image":[{"width":1000,"height":657,"url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-affairs-training.webp","type":"image\/webp"}],"twitter_card":"summary_large_image","twitter_misc":{"Est. tempo de leitura":"5 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/","url":"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/","name":"Treinamento em Assuntos Regulat\u00f3rios FDA | Dispositivos M\u00e9dicos","isPartOf":{"@id":"https:\/\/sobelconsult.com\/pt-br\/#website"},"primaryImageOfPage":{"@id":"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/#primaryimage"},"image":{"@id":"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/#primaryimage"},"thumbnailUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-affairs-training.webp","datePublished":"2025-06-01T13:00:00+00:00","dateModified":"2026-02-02T18:10:47+00:00","description":"Treinamento em assuntos regulat\u00f3rios conduzido por especialistas que fortalece o gerenciamento de riscos, a conformidade e o desempenho da equipe. 21 CFR 820 e ISO 10993-1.","breadcrumb":{"@id":"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/#breadcrumb"},"inLanguage":"pt-BR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/"]}]},{"@type":"ImageObject","inLanguage":"pt-BR","@id":"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/#primaryimage","url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-affairs-training.webp","contentUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-affairs-training.webp","width":1000,"height":657,"caption":"An online training course about regulatory affairs FDA"},{"@type":"BreadcrumbList","@id":"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/treinamento-assuntos-regulatorios-fda\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/sobelconsult.com\/pt-br\/home\/"},{"@type":"ListItem","position":2,"name":"Nossas solu\u00e7\u00f5es EUA","item":"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/"},{"@type":"ListItem","position":3,"name":"Treinamento em regulamenta\u00e7\u00e3o de dispositivos m\u00e9dicos nos EUA"}]},{"@type":"WebSite","@id":"https:\/\/sobelconsult.com\/pt-br\/#website","url":"https:\/\/sobelconsult.com\/pt-br\/","name":"Sobel","description":"Regulatory Consultancy","publisher":{"@id":"https:\/\/sobelconsult.com\/pt-br\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/sobelconsult.com\/pt-br\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"pt-BR"},{"@type":"Organization","@id":"https:\/\/sobelconsult.com\/pt-br\/#organization","name":"Sobel","url":"https:\/\/sobelconsult.com\/pt-br\/","logo":{"@type":"ImageObject","inLanguage":"pt-BR","@id":"https:\/\/sobelconsult.com\/pt-br\/#\/schema\/logo\/image\/","url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png","contentUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png","width":741,"height":290,"caption":"Sobel"},"image":{"@id":"https:\/\/sobelconsult.com\/pt-br\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/sobelconsult.com\/pt-br\/wp-json\/wp\/v2\/pages\/7711","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sobelconsult.com\/pt-br\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sobelconsult.com\/pt-br\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/pt-br\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/pt-br\/wp-json\/wp\/v2\/comments?post=7711"}],"version-history":[{"count":5,"href":"https:\/\/sobelconsult.com\/pt-br\/wp-json\/wp\/v2\/pages\/7711\/revisions"}],"predecessor-version":[{"id":28199,"href":"https:\/\/sobelconsult.com\/pt-br\/wp-json\/wp\/v2\/pages\/7711\/revisions\/28199"}],"up":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/pt-br\/wp-json\/wp\/v2\/pages\/7775"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/pt-br\/wp-json\/wp\/v2\/media\/7246"}],"wp:attachment":[{"href":"https:\/\/sobelconsult.com\/pt-br\/wp-json\/wp\/v2\/media?parent=7711"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}