{"id":7929,"date":"2025-06-01T10:00:00","date_gmt":"2025-06-01T13:00:00","guid":{"rendered":"https:\/\/sobelconsult.com\/evaluation-clinique-bresil\/"},"modified":"2026-02-23T08:42:53","modified_gmt":"2026-02-23T11:42:53","slug":"clinical-evaluation-brazil","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/fr\/our-solutions-brazil\/clinical-evaluation-brazil\/","title":{"rendered":"\u00c9valuation clinique - Br\u00e9sil"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7929\" class=\"elementor elementor-7929 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\">\u00c9valuation clinique des dispositifs m\u00e9dicaux par Anvisa<\/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\">L&rsquo;\u00e9valuation clinique est la pierre angulaire des soumissions de dispositifs m\u00e9dicaux au Br\u00e9sil. Les fabricants doivent fournir des preuves document\u00e9es d\u00e9montrant que leur dispositif est s\u00fbr, efficace et qu&rsquo;il fonctionne comme pr\u00e9vu. Chez Sobel, nous vous guidons \u00e0 chaque \u00e9tape du processus d&rsquo;\u00e9valuation clinique de l&rsquo;Anvisa, vous aidant ainsi \u00e0 r\u00e9pondre efficacement aux attentes de la r\u00e9glementation br\u00e9silienne.  <\/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%3DeyJpZCI6ODQyOCwidG9nZ2xlIjpmYWxzZX0%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\">Obtenez l'aide d'un expert<\/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\">Pour qui ?<\/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\">Fabricants de dispositifs m\u00e9dicaux (classe I - IV) \u00e0 la recherche d'une documentation clinique conforme \u00e0 la directive Anvisa n\u00b0 31\/2020.<\/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\">Entreprises pr\u00e9parant des demandes d'enregistrement ou de renouvellement qui n\u00e9cessitent un plan d'\u00e9valuation clinique (PEC) et un rapport d'\u00e9valuation clinique (REC).<\/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\">Organisations visant \u00e0 mettre \u00e0 jour, r\u00e9viser ou r\u00e9\u00e9valuer la documentation existante sur l'\u00e9valuation clinique.<\/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\">Les fabricants de dispositifs \u00e0 haut risque (classes III et IV) qui ont besoin d'aide pour d\u00e9finir une strat\u00e9gie d'\u00e9valuation clinique avant la soumission d'une demande d'homologation.<\/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-18564\" 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\">De l&rsquo;identification des lacunes en mati\u00e8re de donn\u00e9es au d\u00e9veloppement et \u00e0 la mise \u00e0 jour d&rsquo;une documentation conforme, Sobel poss\u00e8de l&rsquo;expertise n\u00e9cessaire pour guider votre entreprise \u00e0 chaque \u00e9tape du processus d&rsquo;\u00e9valuation clinique d&rsquo;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%3DeyJpZCI6ODQyOCwidG9nZ2xlIjpmYWxzZX0%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\">Obtenez de l'aide !<\/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-18570\" 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\">Pourquoi avez-vous besoin de ce service ?<\/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\">L&rsquo;\u00e9valuation clinique est obligatoire en vertu de la r\u00e9glementation br\u00e9silienne et constitue la base des preuves de s\u00e9curit\u00e9 et de performance de votre produit.<\/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\">Un processus structur\u00e9 d&rsquo;\u00e9valuation clinique Anvisa r\u00e9duit le risque de rejet, de retard ou de demande de tests suppl\u00e9mentaires.<\/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\">Une \u00e9valuation clinique Anvisa bien structur\u00e9e favorise la conformit\u00e9 aux normes internationales et renforce votre pr\u00e9paration aux audits 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\">Conformit\u00e9 totale tout au long du cycle de vie de votre \u00e9valuation clinique<\/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\">Sans \u00e9valuation clinique, votre dispositif m\u00e9dical ne peut pas d\u00e9montrer qu&rsquo;il est conforme aux exigences d&rsquo;Anvisa en mati\u00e8re de s\u00e9curit\u00e9 et de performances cliniques.<\/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\">Obtenir la conformit\u00e9 clinique gr\u00e2ce \u00e0 une \u00e9valuation conforme \u00e0 l'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=\"#\" >Planification<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Nous d\u00e9finissons la strat\u00e9gie d'\u00e9valuation clinique conform\u00e9ment \u00e0 la directive Anvisa n\u00b0 31\/2020, au RDC 848\/2024 et aux meilleures pratiques internationales.<\/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=\"#\" >Rapports<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Nous consolidons les donn\u00e9es de la litt\u00e9rature, les preuves cliniques et l'\u00e9valuation des b\u00e9n\u00e9fices et des risques dans un document complet pr\u00eat \u00e0 \u00eatre soumis \u00e0 l'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=\"#\" >Livraison<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Vous recevez votre rapport CEP, CER ou combin\u00e9 sous la forme d'une documentation pr\u00eate \u00e0 \u00eatre audit\u00e9e, qui soutient la conformit\u00e9 r\u00e9glementaire et la cr\u00e9dibilit\u00e9 clinique.<\/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%3DeyJpZCI6ODQyOCwidG9nZ2xlIjpmYWxzZX0%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\">Commencez d\u00e8s maintenant !<\/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\">Services connexes <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\">Sobel d\u00e9veloppe votre documentation d&rsquo;\u00e9valuation clinique avec rigueur scientifique et pr\u00e9cision r\u00e9glementaire, ouvrant la voie \u00e0 des soumissions conformes et r\u00e9ussies au Br\u00e9sil. Vous pouvez \u00e9galement compl\u00e9ter votre processus d&rsquo;\u00e9valuation clinique Anvisa avec : <\/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\">Analyse des lacunes de l'\u00e9valuation clinique<\/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\">Identifiez les lacunes dans les donn\u00e9es, \u00e9valuez les informations disponibles et d\u00e9finissez ce qui manque pour soutenir une \u00e9valuation clinique solide et conforme.<\/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\">Soutien \u00e0 la strat\u00e9gie d'\u00e9valuation clinique<\/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\">Conseils techniques pour d\u00e9finir votre approche de l&rsquo;\u00e9valuation, y compris les comparateurs, les sources documentaires et les recommandations d&rsquo;\u00e9tudes possibles pour les dispositifs de classe III et 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\">Mises \u00e0 jour et r\u00e9visions<\/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\">Mettre \u00e0 jour ou soumettre \u00e0 un examen critique votre CEP ou CER existant afin de refl\u00e9ter les nouvelles donn\u00e9es ou les derni\u00e8res exigences de l&rsquo;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>Si vous avez besoin de l&rsquo;un de ces services compl\u00e9mentaires, <a href=\"https:\/\/sobelconsult.com\/fr\/contact-us\/\" target=\"_blank\" rel=\"noopener\">contactez nos consultants<\/a> - nous vous aiderons \u00e0 trouver la bonne voie pour votre produit et vos objectifs r\u00e9glementaires.<\/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\">Renforcez votre \u00e9valuation clinique Anvisa avec l'aide d'un expert<\/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\">Sobel transforme les exigences cliniques complexes en une documentation claire et pr\u00eate \u00e0 \u00eatre soumise \u00e0 la r\u00e9glementation. Gr\u00e2ce \u00e0 une m\u00e9thodologie structur\u00e9e et \u00e0 une \u00e9quipe multidisciplinaire sp\u00e9cialis\u00e9e dans l&rsquo;\u00e9valuation clinique Anvisa, nous vous aidons \u00e0 rendre votre demande scientifiquement solide, conforme et strat\u00e9giquement align\u00e9e sur les r\u00e9glementations br\u00e9siliennes. <\/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%3DeyJpZCI6ODQyOCwidG9nZ2xlIjpmYWxzZX0%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\">Commencez d\u00e8s maintenant !<\/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\">Vous avez encore des questions ? Consultez notre 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. Qu&rsquo;est-ce que l&rsquo;\u00e9valuation clinique selon Anvisa ?<\/b><\/p>\n<p>L&rsquo;\u00e9valuation clinique est un processus r\u00e9glementaire d\u00e9fini dans le guide Anvisa n\u00b0 31\/2020 et le RDC 848\/2024, qui exige des fabricants qu&rsquo;ils d\u00e9montrent la s\u00e9curit\u00e9 et les performances d&rsquo;un dispositif par l&rsquo;analyse de donn\u00e9es cliniques, de la litt\u00e9rature et de preuves concr\u00e8tes.<\/p>\n<p><b>2. Quels sont les documents requis pour l&rsquo;\u00e9valuation clinique Anvisa au Br\u00e9sil ?<\/b><\/p>\n<p>L&rsquo;Anvisa exige un plan d&rsquo;\u00e9valuation clinique (PEC) et un rapport d&rsquo;\u00e9valuation clinique (REC) dans le cadre du processus d&rsquo;\u00e9valuation clinique des dispositifs m\u00e9dicaux. Le PEC d\u00e9finit la strat\u00e9gie et la m\u00e9thodologie d&rsquo;\u00e9valuation, tandis que le REC documente l&rsquo;analyse des preuves cliniques et les conclusions avantages-risques qui en d\u00e9coulent pour \u00e9tayer les demandes d&rsquo;autorisation. <\/p>\n<p><b>3. Quelle est la diff\u00e9rence entre CEP et CER ?<\/b><\/p>\n<p>Le PEC d\u00e9finit la strat\u00e9gie, la m\u00e9thodologie et le champ d&rsquo;application de l&rsquo;\u00e9valuation, tandis que le CER pr\u00e9sente les r\u00e9sultats, l&rsquo;interpr\u00e9tation des donn\u00e9es et les conclusions finales de l&rsquo;\u00e9valuation clinique. Ensemble, ils forment le dossier complet de l&rsquo;\u00e9valuation clinique Anvisa. <\/p>\n<p><b>4. Quand une analyse des lacunes est-elle recommand\u00e9e ?<\/b><\/p>\n<p>Une analyse des lacunes de l&rsquo;\u00e9valuation clinique est utile lorsqu&rsquo;un fabricant souhaite v\u00e9rifier si les donn\u00e9es existantes sont suffisantes pour r\u00e9pondre aux exigences de l&rsquo;Anvisa. Elle identifie les informations manquantes et aide \u00e0 d\u00e9terminer si de nouvelles \u00e9tudes ou sources de donn\u00e9es sont n\u00e9cessaires. <\/p>\n<p><b>5. \u00c0 quelle fr\u00e9quence les documents d&rsquo;\u00e9valuation clinique doivent-ils \u00eatre mis \u00e0 jour ?<\/b><\/p>\n<p>Des mises \u00e0 jour ou des r\u00e9visions sont n\u00e9cessaires lorsque de nouvelles donn\u00e9es cliniques, des changements r\u00e9glementaires ou des modifications du produit interviennent. Dans le cadre du CDR 848\/2024, la mise \u00e0 jour des versions du PEC et de la RCE est essentielle au maintien de l&rsquo;autorisation de mise sur le march\u00e9 et de la conformit\u00e9. <\/p>\n<p><b>6. Quel est le lien entre l&rsquo;\u00e9valuation clinique et le MDSAP ?<\/b><\/p>\n<p>Bien que le MDSAP n&rsquo;\u00e9value pas directement le contenu des CEP ou des CER, le fait de disposer d&rsquo;une documentation structur\u00e9e sur l&rsquo;\u00e9valuation clinique d&rsquo;Anvisa d\u00e9montre l&rsquo;existence de processus de qualit\u00e9 robustes et permet aux autorit\u00e9s participant au MDSAP d&rsquo;\u00eatre pr\u00eates pour l&rsquo;audit.<\/p>\n<p><b>7. Quels types de soutien Sobel fournit-il ?<\/b><\/p>\n<p>Sobel propose la pr\u00e9paration, la mise \u00e0 jour et la r\u00e9vision des documents CEP et CER, la d\u00e9finition de la strat\u00e9gie d&rsquo;\u00e9valuation clinique et l&rsquo;analyse des lacunes. Nos consultants veillent \u00e0 ce que votre documentation r\u00e9ponde aux attentes de l&rsquo;Anvisa et aux attentes internationales. <\/p>\n<p><b>8. Comment puis-je savoir quel service s&rsquo;applique \u00e0 mon appareil ?<\/b><\/p>\n<p>Nos sp\u00e9cialistes analysent la classification de votre produit, les donn\u00e9es actuelles et les besoins r\u00e9glementaires afin de recommander la combinaison exacte de services - qu&rsquo;il s&rsquo;agisse de CEP, de CER, d&rsquo;analyse des lacunes ou de soutien strat\u00e9gique - pour parvenir \u00e0 un alignement complet sur les exigences de l&rsquo;\u00e9valuation clinique d&rsquo;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>Se conformer aux exigences de l&rsquo;\u00e9valuation clinique de l&rsquo;Anvisa. CEP, CER, mises \u00e0 jour, r\u00e9visions et d\u00e9finition de strat\u00e9gies pour les dispositifs m\u00e9dicaux. <\/p>\n","protected":false},"author":11,"featured_media":7118,"parent":8446,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-7929","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>Anvisa Clinical Evaluation | Clinical Safety Services<\/title>\n<meta name=\"description\" content=\"Se conformer aux exigences de l&#039;\u00e9valuation clinique de l&#039;Anvisa. 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