{"id":4845,"date":"2025-06-01T10:00:00","date_gmt":"2025-06-01T13:00:00","guid":{"rendered":"https:\/\/sobelconsult.com\/evaluation-biologique-etats-unis\/"},"modified":"2026-02-19T09:17:34","modified_gmt":"2026-02-19T12:17:34","slug":"biological-evaluation-medical-device","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/","title":{"rendered":"\u00c9valuation biologique - \u00c9tats-Unis"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"4845\" class=\"elementor elementor-4845 elementor-1762\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-36ee959 e-flex e-con-boxed e-con e-parent\" data-id=\"36ee959\" 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-361f640 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"361f640\" 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 biologique des dispositifs m\u00e9dicaux (ISO 10993 BEP &amp; BER)<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2d6f385 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"2d6f385\" 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\":\"A biological evaluation for a medical device requires a structured, risk-based approach aligned with ISO 10993 and the FDA\u2019s Guidance for Use of ISO 10993-1. Sobel supports manufacturers by developing Biological Evaluation Plans (BEPs), Biological Evaluation Reports (BERs), and strategic documentation that demonstrate biological safety in alignment with FDA expectations. \"}]\" data-inline-monday=\"true\">L&rsquo;\u00e9valuation biologique d&rsquo;un dispositif m\u00e9dical n\u00e9cessite une approche structur\u00e9e et bas\u00e9e sur le risque, conforme \u00e0 la norme ISO 10993-1 et au guide d&rsquo;utilisation de la norme ISO 10993-1 de la FDA. Sobel soutient les fabricants en \u00e9laborant des plans d&rsquo;\u00e9valuation biologique (BEP), des rapports d&rsquo;\u00e9valuation biologique (BER) et une documentation strat\u00e9gique qui d\u00e9montrent la s\u00e9curit\u00e9 biologique conform\u00e9ment aux attentes de la FDA. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-00769c3 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"00769c3\" 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-1754650 e-flex e-con-boxed e-con e-parent\" data-id=\"1754650\" 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-32f5e36 e-con-full e-flex e-con e-child\" data-id=\"32f5e36\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-126c326 e-con-full e-transform e-flex e-con e-child\" data-id=\"126c326\" 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-07506a4 elementor-widget elementor-widget-heading\" data-id=\"07506a4\" 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-ff70bdd elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"ff70bdd\" 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-5e60954 elementor-align-end elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"5e60954\" 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\">Les fabricants de dispositifs anciens dont l'utilisation est ancienne mais dont la documentation sur la biocompatibilit\u00e9 est incompl\u00e8te.<\/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 soumissions 510(k), PMA ou De Novo.<\/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\">Dispositifs comportant des mat\u00e9riaux complexes, des rev\u00eatements, des additifs ou des profils chimiques peu clairs.<\/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\">\u00c9quipes ayant besoin de conseils d'experts sur les attentes de la FDA en mati\u00e8re d'\u00e9valuation biologique des dispositifs m\u00e9dicaux.<\/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 organisations qui recherchent une approche structur\u00e9e et fond\u00e9e sur les risques en mati\u00e8re de s\u00e9curit\u00e9 biologique.<\/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-c801fad e-con-full e-flex e-con e-child\" data-id=\"c801fad\" 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-e5bc40e elementor-widget elementor-widget-image\" data-id=\"e5bc40e\" 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-a12d103 e-flex e-con-boxed e-con e-parent\" data-id=\"a12d103\" 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-9d5e78c elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"9d5e78c\" 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\":\"Sobel helps you transform historical data, material information, toxicological evidence, and scientific rationale into a strong Biological Evaluation of medical device.\"}]\" data-inline-monday=\"true\">Gr\u00e2ce \u00e0 une strat\u00e9gie claire et \u00e0 une justification bien \u00e9tay\u00e9e, votre demande devient plus pr\u00e9visible, plus efficace et plus d\u00e9fendable sur le plan scientifique.<\/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-0f6fd86 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"0f6fd86\" 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-229a749 e-flex e-con-boxed e-con e-parent\" data-id=\"229a749\" 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-af9a15d elementor-widget-mobile__width-inherit elementor-widget elementor-widget-image\" data-id=\"af9a15d\" 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-cb5e048 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"cb5e048\" 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-2339b28 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"2339b28\" 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-a037c89 e-con-full e-flex e-con e-child\" data-id=\"a037c89\" 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-4dee759 elementor-widget elementor-widget-text-editor\" data-id=\"4dee759\" 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\":\"Manufacturers must demonstrate biological safety using an ISO 10993\u2013aligned, risk-based approach that meets FDA expectations for medical device submissions.\"}]\" data-inline-monday=\"true\">Les fabricants doivent d\u00e9montrer la s\u00e9curit\u00e9 biologique \u00e0 l&rsquo;aide d&rsquo;une approche bas\u00e9e sur les risques, conforme \u00e0 la norme ISO 10993, qui r\u00e9pond aux attentes de la FDA en mati\u00e8re de soumissions de dispositifs m\u00e9dicaux.<\/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-5006fd7 e-con-full e-flex e-con e-child\" data-id=\"5006fd7\" 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-5ca1608 elementor-widget elementor-widget-text-editor\" data-id=\"5ca1608\" 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\":\"Legacy or partially documented devices often lack complete material, toxicological, or historical data, requiring structured evaluation and scientific justification.\"}]\" data-inline-monday=\"true\">Les dispositifs anciens ou partiellement document\u00e9s manquent souvent de donn\u00e9es compl\u00e8tes sur les mat\u00e9riaux, la toxicologie ou l&rsquo;historique, ce qui n\u00e9cessite une \u00e9valuation structur\u00e9e et une justification scientifique.<\/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-6599c8d e-con-full e-flex e-con e-child\" data-id=\"6599c8d\" 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-91150d5 elementor-widget elementor-widget-text-editor\" data-id=\"91150d5\" 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 clear, defensible biological evaluation medical device package reduces FDA questions, avoids unnecessary testing, and strengthens your overall regulatory strategy.\"}]\" data-inline-monday=\"true\">Un dossier d&rsquo;\u00e9valuation biologique clair et d\u00e9fendable r\u00e9duit les questions de la FDA, \u00e9vite les tests inutiles et renforce votre strat\u00e9gie r\u00e9glementaire globale.<\/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-03f6806 e-flex e-con-boxed e-con e-parent\" data-id=\"03f6806\" 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-bc2e4e3 e-con-full e-flex e-con e-child\" data-id=\"bc2e4e3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ae4fb42 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"ae4fb42\" 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\">Exigences en mati\u00e8re d'\u00e9valuation biologique des dispositifs m\u00e9dicaux<\/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-747a32c e-con-full e-flex e-con e-child\" data-id=\"747a32c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-271033f elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"271033f\" 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>L&rsquo;\u00e9valuation biologique des dispositifs m\u00e9dicaux n\u00e9cessite une \u00e9valuation structur\u00e9e, bas\u00e9e sur les risques et conforme \u00e0 la norme ISO 10993-1, comprenant la caract\u00e9risation des mat\u00e9riaux, l&rsquo;\u00e9valuation des risques toxicologiques et l&rsquo;\u00e9valuation de la dur\u00e9e du contact avec le patient et de l&rsquo;exposition.<\/p><p><strong>  Les autorit\u00e9s r\u00e9glementaires telles que la FDA et les organismes internationaux notifi\u00e9s attendent des fabricants qu&rsquo;ils documentent cette \u00e9valuation au moyen de plans d&rsquo;\u00e9valuation biologique (BEP) et de rapports d&rsquo;\u00e9valuation biologique (BER) dans le cadre des demandes d&rsquo;autorisation.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7382bf8 e-flex e-con-boxed e-con e-parent\" data-id=\"7382bf8\" 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-e75bb60 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"e75bb60\" 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\">Une \u00e9valuation biologique qui soutient votre strat\u00e9gie r\u00e9glementaire - de la planification \u00e0 la justification finale.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-60132fe elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"60132fe\" 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_60132fe *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_60132fe{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_60132fe .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_60132fe .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_60132fe .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_60132fe .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_60132fe .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_60132fe .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_60132fe .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_60132fe .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_60132fe  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_60132fe  .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_60132fe .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_60132fe .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_60132fe .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_60132fe .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_60132fe .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_60132fe .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_60132fe .ue-item-bullet i, #uc_horizontal_timeline_elementor_60132fe .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_60132fe .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_60132fe .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_60132fe .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_60132fe .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_60132fe .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_60132fe .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_60132fe .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_60132fe .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_60132fe .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_60132fe\">\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_60132fe\" data-custom-sethtml=\"true\"  >\n     \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-58fbbfd\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >D\u00e9finition de la strat\u00e9gie<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Nous analysons la cat\u00e9gorie de votre dispositif, les mat\u00e9riaux, l'histoire clinique et l'utilisation pr\u00e9vue afin de d\u00e9finir l'approche d'\u00e9valuation biologique la plus appropri\u00e9e.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-5ca2a2a\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Compilation des donn\u00e9es et examen scientifique<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Nous recueillons et interpr\u00e9tons les informations historiques, les donn\u00e9es chimiques, les profils toxicologiques et toutes les preuves disponibles apr\u00e8s la mise sur le march\u00e9.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-9cdd855\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Identification des lacunes et recommandations<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Lorsque les donn\u00e9es sont insuffisantes, nous recommandons des essais cibl\u00e9s ou pr\u00e9parons une justification scientifique solide pour l'omission d'un essai, conform\u00e9ment \u00e0 la norme ISO 10993-1 et aux orientations de la FDA.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-e43fc00\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >\u00c9valuation et documentation des risques biologiques<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Nous traduisons toutes les donn\u00e9es en une description coh\u00e9rente, bas\u00e9e sur les risques, qui soutient votre demande aupr\u00e8s de la FDA et r\u00e9pond aux attentes internationales.<\/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-2dd7a95 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"2dd7a95\" 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-05372fc animated-slow e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"05372fc\" 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-7094689 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"7094689\" 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\">Quel service s'applique \u00e0 votre dispositif m\u00e9dical ?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-354dce8 elementor-widget elementor-widget-text-editor\" data-id=\"354dce8\" 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\":\"At Sobel, you can request the combined BEP + BER package, or complementary toxicological and strategic services.\"}]\" data-inline-monday=\"true\">Chez Sobel, vous pouvez demander l&rsquo;offre combin\u00e9e BEP + BER, ou des services toxicologiques et strat\u00e9giques compl\u00e9mentaires.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-152686a e-flex e-con-boxed e-con e-child\" data-id=\"152686a\" 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-f8c83db e-con-full e-flex e-con e-child\" data-id=\"f8c83db\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-195a5be elementor-widget elementor-widget-heading\" data-id=\"195a5be\" 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\">BEP + BER :<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-32784ba elementor-widget elementor-widget-text-editor\" data-id=\"32784ba\" 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\":\"The most complete pathway, ensuring a consistent strategy and final reporting \u2014 reducing FDA questions, omissions, and review delays.\"}]\" data-inline-monday=\"true\">La voie la plus compl\u00e8te, garantissant une strat\u00e9gie coh\u00e9rente et un rapport final - r\u00e9duisant les questions de la FDA, les omissions et les retards d&rsquo;examen.<\/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-8d9b389 e-con-full e-flex e-con e-child\" data-id=\"8d9b389\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3633190 elementor-widget elementor-widget-heading\" data-id=\"3633190\" 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\">\u00c9valuation du risque toxicologique (TRA)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ae90362 elementor-widget elementor-widget-text-editor\" data-id=\"ae90362\" 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\":\"Toxicological review of relevant materials, components, substances, historical use, exposure, and biological safety data.\"}]\" data-inline-monday=\"true\">Examen toxicologique des mat\u00e9riaux, des composants, des substances, de l&rsquo;utilisation historique, de l&rsquo;exposition et des donn\u00e9es de s\u00e9curit\u00e9 biologique pertinents.<\/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-9cf3b36 e-con-full e-flex e-con e-child\" data-id=\"9cf3b36\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d8b058e elementor-widget elementor-widget-heading\" data-id=\"d8b058e\" 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 aux questions d'\u00e9valuation biologique<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7e35e67 elementor-widget elementor-widget-text-editor\" data-id=\"7e35e67\" 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\":\"Technical guidance to define a biological evaluation strategy following ISO 10993-1 and FDA guidance, including expert recommendations for necessary tests.\"}]\" data-inline-monday=\"true\">Conseils techniques pour d\u00e9finir une strat\u00e9gie d&rsquo;\u00e9valuation biologique conform\u00e9ment \u00e0 la norme ISO 10993-1 et aux directives de la FDA, y compris des recommandations d&rsquo;experts pour les tests n\u00e9cessaires.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-033acad e-flex e-con-boxed e-con e-parent\" data-id=\"033acad\" 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-63c690b e-con-full e-flex e-con e-child\" data-id=\"63c690b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f51e692 elementor-widget__width-inherit elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"f51e692\" 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-7af7e3d elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"7af7e3d\" 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-1f01252 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"1f01252\" 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 strengthens your entire biological evaluation medical device process with complementary services that support FDA submissions:\"}]\" data-inline-monday=\"true\">Sobel renforce l&rsquo;ensemble de votre processus d&rsquo;\u00e9valuation biologique des dispositifs m\u00e9dicaux avec des <a href=\"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/\" target=\"_blank\" rel=\"noopener\">services compl\u00e9mentaires qui soutiennent les soumissions \u00e0 la FDA<\/a>:<\/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-0298a8c e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"0298a8c\" 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-1467aa1 e-con-full e-flex e-con e-child\" data-id=\"1467aa1\" 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-6e1be0f elementor-widget elementor-widget-heading\" data-id=\"6e1be0f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/regulatory-affairs-training\/\" target=\"_blank\">Formation r\u00e9glementaire<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-54c6ba5 elementor-widget elementor-widget-text-editor\" data-id=\"54c6ba5\" 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\":\"Expert-led training to help teams understand ISO 10993-1 and FDA expectations.\"}]\" data-inline-monday=\"true\">Formation dispens\u00e9e par des experts pour aider les \u00e9quipes \u00e0 comprendre la norme ISO 10993-1 et les attentes de la FDA.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f718019 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"f718019\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/regulatory-affairs-training\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Voir plus<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d2ef24e e-con-full e-flex e-con e-child\" data-id=\"d2ef24e\" 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-34d0762 elementor-widget elementor-widget-heading\" data-id=\"34d0762\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/fda-medical-device-regulatory-consulting\/\" target=\"_blank\">Conseil en r\u00e9glementation<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8d3654d elementor-widget elementor-widget-text-editor\" data-id=\"8d3654d\" 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\":\"Support for CEP and CER development, including strategic planning, literature reviews (LSP, LSW and LSR) and more.\"}]\" data-inline-monday=\"true\">Assistance pour la notification pr\u00e9alable 510(k), les soumissions \u00e0 la FDA, l&rsquo;enregistrement, l&rsquo;UDI, etc.<\/p><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2b43892 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"2b43892\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/fda-medical-device-regulatory-consulting\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Voir plus<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3ea98d3 e-con-full e-flex e-con e-child\" data-id=\"3ea98d3\" 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-03c8b02 elementor-widget elementor-widget-heading\" data-id=\"03c8b02\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/medical-device-supplier-audit-qualification\/\" target=\"_blank\">Audit et qualification des fournisseurs<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c2cca3f elementor-widget elementor-widget-text-editor\" data-id=\"c2cca3f\" 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\":\"Strengthen your supply chain with supplier audit and qualification services.\"}]\" data-inline-monday=\"true\">Renforcez votre cha\u00eene d&rsquo;approvisionnement gr\u00e2ce \u00e0 des services d&rsquo;audit et de qualification des fournisseurs.<\/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-34c801e elementor-align-center elementor-widget elementor-widget-button\" data-id=\"34c801e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/medical-device-supplier-audit-qualification\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Voir plus<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a1f745c e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"a1f745c\" 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-6c39265 e-con-full e-flex e-con e-child\" data-id=\"6c39265\" 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-88bd768 e-con-full e-flex e-con e-child\" data-id=\"88bd768\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-76f13f2 elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"76f13f2\" 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\">B\u00e9n\u00e9ficiez du soutien d'experts en \u00e9valuation biologique<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c9e85a6 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"c9e85a6\" 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\":\"Let Sobel guide you through a structured, compliant, and efficient biological evaluation process for your medical device. We translate all data into a coherent, risk-based narrative that supports your FDA submission and meets global expectations.\"}]\" data-inline-monday=\"true\">Laissez Sobel vous guider dans un processus d&rsquo;\u00e9valuation biologique structur\u00e9, conforme et efficace pour votre dispositif m\u00e9dical. Nous traduisons toutes les donn\u00e9es en une description coh\u00e9rente, bas\u00e9e sur les risques, qui soutient votre demande aupr\u00e8s de la FDA et r\u00e9pond aux attentes internationales.<\/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-7b19bd8 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"7b19bd8\" 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-d625501 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"d625501\" 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-729a6f7 elementor-widget__width-inherit elementor-widget elementor-widget-toggle\" data-id=\"729a6f7\" 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 qu&rsquo;un plan d&rsquo;\u00e9valuation biologique (PEB) ?<\/b><\/p>\n<p>Une MPE d\u00e9crit la strat\u00e9gie, la justification et les \u00e9tapes que votre entreprise suivra pour d\u00e9montrer la s\u00e9curit\u00e9 biologique conform\u00e9ment \u00e0 la norme ISO 10993 et aux directives de la FDA.<\/p>\n<p><b>2. Quand dois-je pr\u00e9parer un MPE pour mon appareil ?<\/b><\/p>\n<p>Une MPE doit \u00eatre \u00e9labor\u00e9e avant d&rsquo;effectuer des essais de biocompatibilit\u00e9 ou de mettre \u00e0 jour des donn\u00e9es historiques. Il garantit que les essais, la justification et la collecte des donn\u00e9es sont conformes aux attentes de la FDA pour votre cat\u00e9gorie de dispositifs, vos mat\u00e9riaux et votre profil de contact avec le patient. <\/p>\n<p><b>3. Qu&rsquo;est-ce qu&rsquo;un rapport d&rsquo;\u00e9valuation biologique (BER) ?<\/b><\/p>\n<p>Un REC regroupe toutes les donn\u00e9es de biocompatibilit\u00e9, les \u00e9valuations toxicologiques, les r\u00e9sultats des tests, les informations historiques et les justifications scientifiques en une conclusion finale bas\u00e9e sur le risque concernant la s\u00e9curit\u00e9 biologique, \u00e0 soumettre \u00e0 la FDA.<\/p>\n<p><b>4. Quand un TEB est-il n\u00e9cessaire ?<\/b><\/p>\n<p>Un REC est n\u00e9cessaire une fois que les essais et la collecte de donn\u00e9es sont termin\u00e9s, et vous devez pr\u00e9senter une \u00e9valuation compl\u00e8te de la s\u00e9curit\u00e9 biologique pour les soumissions 510(k), PMA ou De Novo.<\/p>\n<p><b>5. La FDA accepte-t-elle les MPE et les REC \u00e9labor\u00e9s conform\u00e9ment \u00e0 la norme ISO 10993-1 ?<\/b><\/p>\n<p>Oui. La FDA s&rsquo;aligne sur la norme ISO 10993-1 mais applique des attentes suppl\u00e9mentaires d\u00e9crites dans le guide de la FDA pour l&rsquo;utilisation de la norme ISO 10993-1. Une demande doit satisfaire \u00e0 la fois \u00e0 la norme internationale et aux interpr\u00e9tations sp\u00e9cifiques aux \u00c9tats-Unis.  <\/p>\n<p><b>6. Puis-je utiliser des donn\u00e9es historiques au lieu d&rsquo;effectuer de nouveaux tests ?<\/b><\/p>\n<p>Oui, si cela est justifi\u00e9. La FDA autorise l&rsquo;utilisation de donn\u00e9es de biocompatibilit\u00e9 existantes, y compris des essais ant\u00e9rieurs, des informations sur les mat\u00e9riaux ou de la litt\u00e9rature toxicologique. Toutefois, la justification doit \u00eatre scientifiquement fond\u00e9e, clairement document\u00e9e dans le MPE et enti\u00e8rement interpr\u00e9t\u00e9e dans le REC.  <\/p>\n<p><b>7. Que faire si mon dispositif est un produit ancien dont les donn\u00e9es de biocompatibilit\u00e9 sont obsol\u00e8tes ou incompl\u00e8tes ?<\/b><\/p>\n<p>Cette situation est tr\u00e8s fr\u00e9quente. Un MPE peut d\u00e9finir une strat\u00e9gie moderne pour mettre \u00e0 jour ou compl\u00e9ter la documentation existante. Le REC consolidera les preuves nouvelles et historiques, en fournissant une conclusion bas\u00e9e sur le risque et align\u00e9e sur les attentes actuelles de la FDA.  <\/p>\n<p><strong>8. Quels sont les documents g\u00e9n\u00e9ralement requis pour r\u00e9aliser une \u00e9valuation biologique des dispositifs m\u00e9dicaux ?<\/strong><\/p>\n<p>Une \u00e9valuation biologique compl\u00e8te comprend g\u00e9n\u00e9ralement un plan d&rsquo;\u00e9valuation biologique (BEP), un rapport d&rsquo;\u00e9valuation biologique (BER), des donn\u00e9es de caract\u00e9risation chimique, une \u00e9valuation des risques toxicologiques le cas \u00e9ch\u00e9ant, et une documentation de gestion des risques conforme aux exigences des normes ISO 10993 et ISO 14971.<\/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>\u00c9valuation biologique des dispositifs m\u00e9dicaux conform\u00e9ment \u00e0 la norme ISO 10993. Sobel d\u00e9veloppe des BEP, BER pour soutenir les soumissions de la FDA et les soumissions globales. <\/p>\n","protected":false},"author":11,"featured_media":25336,"parent":7788,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-4845","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>\u00c9valuation biologique des dispositifs m\u00e9dicaux aux \u00c9tats-Unis<\/title>\n<meta name=\"description\" content=\"Renforcez votre demande aupr\u00e8s de la FDA avec le BEP, le BER et le soutien toxicologique. Sobel fournit une documentation claire et d\u00e9fendable sur l&#039;\u00e9valuation biologique des dispositifs m\u00e9dicaux.\" \/>\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\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u00c9valuation biologique - \u00c9tats-Unis\" \/>\n<meta property=\"og:description\" content=\"Renforcez votre demande aupr\u00e8s de la FDA avec le BEP, le BER et le soutien toxicologique. Sobel fournit une documentation claire et d\u00e9fendable sur l&#039;\u00e9valuation biologique des dispositifs m\u00e9dicaux.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/\" \/>\n<meta property=\"og:site_name\" content=\"Sobel\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-19T12:17:34+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/md-eng-services-hero-sec-desktop.png\" \/>\n\t<meta property=\"og:image:width\" content=\"2200\" \/>\n\t<meta property=\"og:image:height\" content=\"1236\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data1\" content=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/\",\"url\":\"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/\",\"name\":\"\u00c9valuation biologique des dispositifs m\u00e9dicaux aux \u00c9tats-Unis\",\"isPartOf\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/md-eng-services-hero-sec-desktop.png\",\"datePublished\":\"2025-06-01T13:00:00+00:00\",\"dateModified\":\"2026-02-19T12:17:34+00:00\",\"description\":\"Renforcez votre demande aupr\u00e8s de la FDA avec le BEP, le BER et le soutien toxicologique. Sobel fournit une documentation claire et d\u00e9fendable sur l'\u00e9valuation biologique des dispositifs m\u00e9dicaux.\",\"breadcrumb\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/#breadcrumb\"},\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/#primaryimage\",\"url\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/md-eng-services-hero-sec-desktop.png\",\"contentUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/md-eng-services-hero-sec-desktop.png\",\"width\":2200,\"height\":1236,\"caption\":\"Composition featuring the United States flag on one side, a light blue gradient, and medical equipment on the other.\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Accueil\",\"item\":\"https:\/\/sobelconsult.com\/fr\/home\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Nos solutions USA\",\"item\":\"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"\u00c9valuation biologique &#8211; \u00c9tats-Unis\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/#website\",\"url\":\"https:\/\/sobelconsult.com\/fr\/\",\"name\":\"Sobel\",\"description\":\"Regulatory Consultancy\",\"publisher\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/sobelconsult.com\/fr\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"fr-FR\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/#organization\",\"name\":\"Sobel\",\"url\":\"https:\/\/sobelconsult.com\/fr\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png\",\"contentUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png\",\"width\":741,\"height\":290,\"caption\":\"Sobel\"},\"image\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/#\/schema\/logo\/image\/\"}}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"\u00c9valuation biologique des dispositifs m\u00e9dicaux aux \u00c9tats-Unis","description":"Renforcez votre demande aupr\u00e8s de la FDA avec le BEP, le BER et le soutien toxicologique. Sobel fournit une documentation claire et d\u00e9fendable sur l'\u00e9valuation biologique des dispositifs m\u00e9dicaux.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/","og_locale":"fr_FR","og_type":"article","og_title":"\u00c9valuation biologique - \u00c9tats-Unis","og_description":"Renforcez votre demande aupr\u00e8s de la FDA avec le BEP, le BER et le soutien toxicologique. Sobel fournit une documentation claire et d\u00e9fendable sur l'\u00e9valuation biologique des dispositifs m\u00e9dicaux.","og_url":"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/","og_site_name":"Sobel","article_modified_time":"2026-02-19T12:17:34+00:00","og_image":[{"width":2200,"height":1236,"url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/md-eng-services-hero-sec-desktop.png","type":"image\/png"}],"twitter_card":"summary_large_image","twitter_misc":{"Dur\u00e9e de lecture estim\u00e9e":"7 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/","url":"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/","name":"\u00c9valuation biologique des dispositifs m\u00e9dicaux aux \u00c9tats-Unis","isPartOf":{"@id":"https:\/\/sobelconsult.com\/fr\/#website"},"primaryImageOfPage":{"@id":"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/#primaryimage"},"image":{"@id":"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/#primaryimage"},"thumbnailUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/md-eng-services-hero-sec-desktop.png","datePublished":"2025-06-01T13:00:00+00:00","dateModified":"2026-02-19T12:17:34+00:00","description":"Renforcez votre demande aupr\u00e8s de la FDA avec le BEP, le BER et le soutien toxicologique. Sobel fournit une documentation claire et d\u00e9fendable sur l'\u00e9valuation biologique des dispositifs m\u00e9dicaux.","breadcrumb":{"@id":"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/#breadcrumb"},"inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/"]}]},{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/#primaryimage","url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/md-eng-services-hero-sec-desktop.png","contentUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/md-eng-services-hero-sec-desktop.png","width":2200,"height":1236,"caption":"Composition featuring the United States flag on one side, a light blue gradient, and medical equipment on the other."},{"@type":"BreadcrumbList","@id":"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/biological-evaluation-medical-device\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Accueil","item":"https:\/\/sobelconsult.com\/fr\/home\/"},{"@type":"ListItem","position":2,"name":"Nos solutions USA","item":"https:\/\/sobelconsult.com\/fr\/our-solutions-usa\/"},{"@type":"ListItem","position":3,"name":"\u00c9valuation biologique &#8211; \u00c9tats-Unis"}]},{"@type":"WebSite","@id":"https:\/\/sobelconsult.com\/fr\/#website","url":"https:\/\/sobelconsult.com\/fr\/","name":"Sobel","description":"Regulatory Consultancy","publisher":{"@id":"https:\/\/sobelconsult.com\/fr\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/sobelconsult.com\/fr\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"fr-FR"},{"@type":"Organization","@id":"https:\/\/sobelconsult.com\/fr\/#organization","name":"Sobel","url":"https:\/\/sobelconsult.com\/fr\/","logo":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/sobelconsult.com\/fr\/#\/schema\/logo\/image\/","url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png","contentUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png","width":741,"height":290,"caption":"Sobel"},"image":{"@id":"https:\/\/sobelconsult.com\/fr\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/pages\/4845","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/comments?post=4845"}],"version-history":[{"count":8,"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/pages\/4845\/revisions"}],"predecessor-version":[{"id":32140,"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/pages\/4845\/revisions\/32140"}],"up":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/pages\/7788"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/media\/25336"}],"wp:attachment":[{"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/media?parent=4845"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}