{"id":7920,"date":"2025-06-01T10:00:00","date_gmt":"2025-06-01T13:00:00","guid":{"rendered":"https:\/\/sobelconsult.com\/avaliacao-clinica-brasil\/"},"modified":"2026-02-23T08:42:53","modified_gmt":"2026-02-23T11:42:53","slug":"avaliacao-clinica-anvisa","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/pt-br\/our-solutions-brazil\/avaliacao-clinica-anvisa\/","title":{"rendered":"Avalia\u00e7\u00e3o Cl\u00ednica - Brasil"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7920\" class=\"elementor elementor-7920 elementor-1672\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7ae034d e-flex e-con-boxed e-con e-parent\" data-id=\"7ae034d\" 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-be44787 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"be44787\" 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\">Avalia\u00e7\u00e3o Cl\u00ednica Anvisa para Dispositivos M\u00e9dicos<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5c81dd3 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"5c81dd3\" 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\":\"Clinical evaluation is a cornerstone of medical device submissions in Brazil. Manufacturers must provide documented evidence demonstrating that their device is safe, effective, and performs as intended. At Sobel, we guide you through every stage of the Anvisa Clinical Evaluation process, helping you meet Brazilian regulatory expectations efficiently.\"}]\" data-inline-monday=\"true\">No Brasil, a avalia\u00e7\u00e3o cl\u00ednica Anvisa \u00e9 um elemento-chave para a aprova\u00e7\u00e3o de dispositivos m\u00e9dicos, pois demonstra, por meio de evid\u00eancias documentadas, que o produto \u00e9 seguro, eficaz e cumpre seu desempenho pretendido. A Sobel apoia fabricantes em todas as etapas desse processo, para alinhamento completo com as exig\u00eancias regulat\u00f3rias brasileiras.  <\/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-bc97c6b elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"bc97c6b\" 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-e742675 e-flex e-con-boxed e-con e-parent\" data-id=\"e742675\" 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-423f68a e-con-full e-flex e-con e-child\" data-id=\"423f68a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-16fa276 e-con-full e-transform e-flex e-con e-child\" data-id=\"16fa276\" 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-902f6d8 elementor-widget elementor-widget-heading\" data-id=\"902f6d8\" 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-8d4c7e1 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"8d4c7e1\" 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-357eae5 elementor-align-end elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"357eae5\" 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\">Fabricantes de dispositivos m\u00e9dicos (Classe I - IV) que buscam documenta\u00e7\u00e3o cl\u00ednica em conformidade com a Orienta\u00e7\u00e3o n\u00ba 31\/2020 da Anvisa.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Empresas que preparam documenta\u00e7\u00e3o de submiss\u00e3o ou renova\u00e7\u00e3o e precisam de um Plano de Avalia\u00e7\u00e3o Cl\u00ednica (CEP) e um Relat\u00f3rio de Avalia\u00e7\u00e3o Cl\u00ednica (CER).<\/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 desejam atualizar, revisar ou reavaliar a documenta\u00e7\u00e3o de avalia\u00e7\u00e3o cl\u00ednica existente.<\/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 de dispositivos de alto risco (Classe III e IV) que precisam de suporte para definir uma estrat\u00e9gia de avalia\u00e7\u00e3o cl\u00ednica antes da submiss\u00e3o.<\/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-630bc9b e-con-full e-flex e-con e-child\" data-id=\"630bc9b\" 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-761a324 elementor-widget elementor-widget-image\" data-id=\"761a324\" 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-c8308fe e-flex e-con-boxed e-con e-parent\" data-id=\"c8308fe\" 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-e62808c elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"e62808c\" 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\":\"From identifying data gaps to developing and updating compliant documentation, Sobel has the expertise to guide your company through every step of the Anvisa Clinical Evaluation process.\"}]\" data-inline-monday=\"true\">Da identifica\u00e7\u00e3o de ajustes at\u00e9 o desenvolvimento e atualiza\u00e7\u00e3o de documenta\u00e7\u00e3o, a Sobel tem a expertise necess\u00e1ria para orientar sua empresa em todas as etapas do processo de avalia\u00e7\u00e3o cl\u00ednica da Anvisa.<\/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-c26d71d elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"c26d71d\" 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-d0e98a9 e-flex e-con-boxed e-con e-parent\" data-id=\"d0e98a9\" 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-1c0bcd2 elementor-widget-mobile__width-inherit elementor-widget elementor-widget-image\" data-id=\"1c0bcd2\" 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-6adb5f4 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"6adb5f4\" 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-2232cca e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"2232cca\" 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-ec21d34 e-con-full e-flex e-con e-child\" data-id=\"ec21d34\" 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-7a1a376 elementor-widget elementor-widget-text-editor\" data-id=\"7a1a376\" 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\":\"Clinical evaluation is mandatory under Brazilian regulation, forming the foundation of your product\u2019s safety and performance evidence.\"}]\" data-inline-monday=\"true\">A avalia\u00e7\u00e3o cl\u00ednica \u00e9 obrigat\u00f3ria de acordo com a regulamenta\u00e7\u00e3o brasileira. Ela \u00e9 a base da evid\u00eancia de seguran\u00e7a e desempenho do seu 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-9efbca1 e-con-full e-flex e-con e-child\" data-id=\"9efbca1\" 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-4b3a975 elementor-widget elementor-widget-text-editor\" data-id=\"4b3a975\" 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 structured Anvisa Clinical Evaluation process reduces the risk of rejection, delays, or additional testing requests.\"}]\" data-inline-monday=\"true\">Um processo estruturado de Avalia\u00e7\u00e3o Cl\u00ednica Anvisa reduz o risco de rejei\u00e7\u00e3o, atrasos ou solicita\u00e7\u00f5es de testes adicionais.<\/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-537cf70 e-con-full e-flex e-con e-child\" data-id=\"537cf70\" 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-9eb6f30 elementor-widget elementor-widget-text-editor\" data-id=\"9eb6f30\" 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 well-structured Clinical Evaluation Anvisa supports compliance with international standards and strengthens your readiness for MDSAP audits.\"}]\" data-inline-monday=\"true\">Uma Avalia\u00e7\u00e3o Cl\u00ednica bem estruturada apoia a conformidade com os padr\u00f5es internacionais e fortalece sua documenta\u00e7\u00e3o para as auditorias do MDSAP.<\/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-11680d7 e-flex e-con-boxed e-con e-parent\" data-id=\"11680d7\" 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-cdb90fd e-con-full e-flex e-con e-child\" data-id=\"cdb90fd\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7ed6894 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"7ed6894\" 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\">Conformidade total em todo o ciclo de vida da Avalia\u00e7\u00e3o Cl\u00ednica<\/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-2925e73 e-con-full e-flex e-con e-child\" data-id=\"2925e73\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5762040 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"5762040\" 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\":\"Without a Clinical Evaluation, your medical device cannot demonstrate compliance with Anvisa\u2019s clinical safety and performance requirements.\"}]\" data-inline-monday=\"true\">Sem uma Avalia\u00e7\u00e3o Cl\u00ednica, seu dispositivo m\u00e9dico pode n\u00e3o conseguir demonstrar conformidade com os requisitos de seguran\u00e7a e desempenho cl\u00ednico da Anvisa.<\/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-02b8b3b e-flex e-con-boxed e-con e-parent\" data-id=\"02b8b3b\" 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-3260057 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"3260057\" 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\">Conformidade cl\u00ednica alinhada \u00e0 Anvisa<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b2496f0 elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"b2496f0\" 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_b2496f0 *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_b2496f0{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_b2496f0 .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_b2496f0  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_b2496f0  .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_b2496f0 .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .ue-item-bullet i, #uc_horizontal_timeline_elementor_b2496f0 .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_b2496f0 .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_b2496f0 .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_b2496f0\">\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_b2496f0\" data-custom-sethtml=\"true\"  >\n     \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-4a90fc4\">\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=\"#\" >Planejamento<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Definimos a estrat\u00e9gia de avalia\u00e7\u00e3o cl\u00ednica de acordo com a Orienta\u00e7\u00e3o n\u00ba 31\/2020 da Anvisa, a RDC 848\/2024 e as melhores pr\u00e1ticas internacionais.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-ed34ef6\">\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=\"#\" >Relat\u00f3rios<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Consolidamos os dados da literatura, as evid\u00eancias cl\u00ednicas e as avalia\u00e7\u00f5es de risco-benef\u00edcio em um documento completo, pronto para ser enviado \u00e0 Anvisa.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-a6513ad\">\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=\"#\" >Entrega<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Voc\u00ea recebe seu CEP, CER ou relat\u00f3rio combinado como uma documenta\u00e7\u00e3o pronta para auditoria que apoia a conformidade regulamentar.<\/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-2e49435 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"2e49435\" 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-2192f1e e-flex e-con-boxed e-con e-parent\" data-id=\"2192f1e\" 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-1e28bf4 e-con-full e-flex e-con e-child\" data-id=\"1e28bf4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ac7bbb2 elementor-widget__width-inherit elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"ac7bbb2\" 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-f6fa668 elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"f6fa668\" 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 <br><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f38c595 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"f38c595\" 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\":\"Sobel develops your clinical evaluation documentation with scientific rigor and regulatory precision, paving the way for compliant and successful submissions in Brazil. You can also complement your Anvisa Clinical Evaluation process with:\"}]\" data-inline-monday=\"true\">Identifica\u00e7\u00e3o de gaps (lacunas), avalia\u00e7\u00e3o das informa\u00e7\u00f5es dispon\u00edveis e defini\u00e7\u00e3o do que ainda \u00e9 necess\u00e1rio para sustentar uma avalia\u00e7\u00e3o cl\u00ednica robusta e em conformidade. <\/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-9bb1333 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"9bb1333\" 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-7a90ca2 e-con-full e-flex e-con e-child\" data-id=\"7a90ca2\" 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-574caf6 elementor-widget elementor-widget-heading\" data-id=\"574caf6\" 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\">An\u00e1lise de gaps na avalia\u00e7\u00e3o cl\u00ednica<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0b27b84 elementor-widget elementor-widget-text-editor\" data-id=\"0b27b84\" 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\":\"Identify data gaps, assess available information, and define what is missing to support a strong and compliant clinical evaluation.\"}]\" data-inline-monday=\"true\">Identifique as lacunas de dados, avalie as informa\u00e7\u00f5es dispon\u00edveis e defina o que est\u00e1 faltando para apoiar uma avalia\u00e7\u00e3o cl\u00ednica s\u00f3lida e compat\u00edvel.<\/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-ab629f7 e-con-full e-flex e-con e-child\" data-id=\"ab629f7\" 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-b453b00 elementor-widget elementor-widget-heading\" data-id=\"b453b00\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Suporte \u00e0 estrat\u00e9gia de avalia\u00e7\u00e3o cl\u00ednica<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-377b3c5 elementor-widget elementor-widget-text-editor\" data-id=\"377b3c5\" 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\":\"Technical guidance to define your evaluation approach, including comparators, literature sources, and possible study recommendations for Class III and IV devices.\"}]\" data-inline-monday=\"true\">Orienta\u00e7\u00e3o t\u00e9cnica para definir sua abordagem de avalia\u00e7\u00e3o, incluindo comparadores, fontes de literatura e poss\u00edveis recomenda\u00e7\u00f5es de estudo para dispositivos de Classe III e IV.<\/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>\n\t\t<div class=\"elementor-element elementor-element-87fa910 e-con-full e-flex e-con e-child\" data-id=\"87fa910\" 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-efa76eb elementor-widget elementor-widget-heading\" data-id=\"efa76eb\" 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\">Atualiza\u00e7\u00f5es e revis\u00f5es<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-867dc5d elementor-widget elementor-widget-text-editor\" data-id=\"867dc5d\" 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\":\"Update or critically review your existing CEP or CER to reflect new data or the latest ANVISA requirements.\"}]\" data-inline-monday=\"true\">Atualize ou fa\u00e7a uma revis\u00e3o cr\u00edtica de seu CEP ou CER existente para refletir novos dados ou os requisitos mais recentes da Anvisa.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8bcd9d3 elementor-widget elementor-widget-text-editor\" data-id=\"8bcd9d3\" 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>Se voc\u00ea precisar de qualquer um desses servi\u00e7os complementares, <a href=\"https:\/\/sobelconsult.com\/pt-br\/contact-us\/\" target=\"_blank\" rel=\"noopener\">fale com nossos consultores<\/a> - n\u00f3s o ajudaremos a encontrar o caminho certo para o seu produto e suas metas regulat\u00f3rias.<\/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-1668b9e e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"1668b9e\" 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-75ab090 e-con-full e-flex e-con e-child\" data-id=\"75ab090\" 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-d979597 e-con-full e-flex e-con e-child\" data-id=\"d979597\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-10b76b7 elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"10b76b7\" 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\">Fortale\u00e7a sua Avalia\u00e7\u00e3o Cl\u00ednica Anvisa com suporte especializado<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4377351 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"4377351\" 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\":\"Sobel transforms complex clinical requirements into clear, regulatory-ready documentation. With a structured methodology and a multidisciplinary team specialized in Anvisa Clinical Evaluation, we help make your submission scientifically sound, compliant, and strategically aligned with Brazilian regulations.\"}]\" data-inline-monday=\"true\">A Sobel transforma requisitos cl\u00ednicos complexos em documenta\u00e7\u00e3o clara e pronta para a submiss\u00e3o. Com uma metodologia estruturada e uma equipe multidisciplinar especializada em Avalia\u00e7\u00e3o Cl\u00ednica da Anvisa, ajudamos a tornar sua documenta\u00e7\u00e3o cientificamente s\u00f3lida, em conformidade e alinhada com as normas brasileiras. <\/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-30ca78c elementor-align-center elementor-widget elementor-widget-button\" data-id=\"30ca78c\" 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-73703df e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"73703df\" 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-72f2563 elementor-widget__width-inherit elementor-widget elementor-widget-toggle\" data-id=\"72f2563\" 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-1201\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1201\" 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-1201\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1201\"><p><b>1. O que \u00e9 Avalia\u00e7\u00e3o Cl\u00ednica segundo a Anvisa?<\/b><\/p>\n<p>A Avalia\u00e7\u00e3o Cl\u00ednica \u00e9 um processo regulat\u00f3rio definido na Orienta\u00e7\u00e3o Anvisa n\u00ba 31\/2020 e na RDC 848\/2024, que exige que os fabricantes demonstrem a seguran\u00e7a e o desempenho de um dispositivo por meio da an\u00e1lise de dados cl\u00ednicos, literatura e evid\u00eancias do mundo real.<\/p>\n<p><b>2. Quais documentos s\u00e3o necess\u00e1rios para a Avalia\u00e7\u00e3o Cl\u00ednica da Anvisa no Brasil?<\/b><\/p>\n<p>A Anvisa exige um Plano de Avalia\u00e7\u00e3o Cl\u00ednica (CEP) e um Relat\u00f3rio de Avalia\u00e7\u00e3o Cl\u00ednica (CER) como parte do processo de avalia\u00e7\u00e3o cl\u00ednica de dispositivos m\u00e9dicos. O CEP define a estrat\u00e9gia e a metodologia de avalia\u00e7\u00e3o, enquanto o CER documenta a an\u00e1lise das evid\u00eancias cl\u00ednicas e as conclus\u00f5es resultantes de risco-benef\u00edcio para dar suporte \u00e0s submiss\u00f5es regulat\u00f3rias. <\/p>\n<p><b>3. Qual \u00e9 a diferen\u00e7a entre CEP e CER?<\/b><\/p>\n<p>O CEP define a estrat\u00e9gia, a metodologia e o escopo da avalia\u00e7\u00e3o, enquanto o CER apresenta os resultados, a interpreta\u00e7\u00e3o dos dados e as conclus\u00f5es finais da avalia\u00e7\u00e3o cl\u00ednica. Juntos, eles formam o pacote completo de documenta\u00e7\u00e3o da Avalia\u00e7\u00e3o Cl\u00ednica Anvisa. <\/p>\n<p><b>4. Quando uma an\u00e1lise de gaps (lacunas) \u00e9 recomendada?<\/b><\/p>\n<p>A an\u00e1lise de gaps na Avalia\u00e7\u00e3o Cl\u00ednica \u00e9 \u00fatil quando um fabricante deseja verificar se os dados existentes s\u00e3o suficientes para atender aos requisitos da Anvisa. Ela identifica as informa\u00e7\u00f5es que faltam e ajuda a determinar se s\u00e3o necess\u00e1rios novos estudos ou fontes de dados. <\/p>\n<p><b>5. Com que frequ\u00eancia os documentos de avalia\u00e7\u00e3o cl\u00ednica devem ser atualizados?<\/b><\/p>\n<p>Atualiza\u00e7\u00f5es ou revis\u00f5es s\u00e3o necess\u00e1rias sempre que ocorrem novos dados cl\u00ednicos, altera\u00e7\u00f5es regulat\u00f3rias ou modifica\u00e7\u00f5es no produto. De acordo com a RDC 848\/2024, manter as vers\u00f5es atuais do CEP e do CER \u00e9 fundamental para a autoriza\u00e7\u00e3o de comercializa\u00e7\u00e3o e a conformidade. <\/p>\n<p><b>6. Como a avalia\u00e7\u00e3o cl\u00ednica se relaciona com o MDSAP?<\/b><\/p>\n<p>Embora o MDSAP n\u00e3o avalie diretamente o conte\u00fado do CEP ou do CER, a documenta\u00e7\u00e3o estruturada da Avalia\u00e7\u00e3o Cl\u00ednica da Anvisa demonstra processos de qualidade robustos e apoia a prontid\u00e3o de auditoria para as autoridades participantes do MDSAP.<\/p>\n<p><b>7. Que tipos de suporte a Sobel oferece?<\/b><\/p>\n<p>A Sobel oferece prepara\u00e7\u00e3o, atualiza\u00e7\u00e3o e revis\u00e3o de documentos CEP e CER, defini\u00e7\u00e3o de estrat\u00e9gia de avalia\u00e7\u00e3o cl\u00ednica e an\u00e1lise de lacunas. Nossos consultores te ajudam para que sua documenta\u00e7\u00e3o atenda \u00e0s expectativas da Anvisa e de \u00f3rg\u00e3os internacionais. <\/p>\n<p><b>8. Como posso saber qual servi\u00e7o se aplica ao meu dispositivo?<\/b><\/p>\n<p>Nossos especialistas analisam a classifica\u00e7\u00e3o do seu produto, os dados atuais e as necessidades regulat\u00f3rias para recomendar a combina\u00e7\u00e3o exata de servi\u00e7os (seja CEP, CER, An\u00e1lise de Gaps ou Suporte Estrat\u00e9gico) para alcan\u00e7ar o alinhamento total com os requisitos de Avalia\u00e7\u00e3o Cl\u00ednica da Anvisa.<\/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>Conquiste a conformidade com uma Avalia\u00e7\u00e3o Cl\u00ednica completa. CEP, CER, atualiza\u00e7\u00f5es, revis\u00f5es e defini\u00e7\u00e3o de estrat\u00e9gias para Anvisa. <\/p>\n","protected":false},"author":11,"featured_media":7120,"parent":8387,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-7920","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>Avalia\u00e7\u00e3o Cl\u00ednica para Dispositivos M\u00e9dicos | Anvisa<\/title>\n<meta name=\"description\" content=\"Conquiste a conformidade com uma Avalia\u00e7\u00e3o Cl\u00ednica completa. CEP, CER, atualiza\u00e7\u00f5es, revis\u00f5es e defini\u00e7\u00e3o de estrat\u00e9gias para Anvisa.\" \/>\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\/our-solutions-brazil\/avaliacao-clinica-anvisa\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Avalia\u00e7\u00e3o Cl\u00ednica - Brasil\" \/>\n<meta property=\"og:description\" content=\"Conquiste a conformidade com uma Avalia\u00e7\u00e3o Cl\u00ednica completa. 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