{"id":15974,"date":"2025-10-02T15:59:12","date_gmt":"2025-10-02T18:59:12","guid":{"rendered":"https:\/\/sobelconsult.com\/materiais\/bep-ber-usa\/"},"modified":"2025-12-23T14:46:17","modified_gmt":"2025-12-23T17:46:17","slug":"bep-ber-usa","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/fr\/materiais\/bep-ber-usa\/","title":{"rendered":"\u00c9valuation biologique pour les dispositifs m\u00e9dicaux de la FDA | BEP &amp; BER"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"15974\" class=\"elementor elementor-15974 elementor-15972\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d9e40ba e-flex e-con-boxed e-con e-parent\" data-id=\"d9e40ba\" 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-bd641f0 elementor-widget__width-initial elementor-widget elementor-widget-theme-site-logo elementor-widget-image\" data-id=\"bd641f0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-site-logo.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"741\" height=\"290\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png\" class=\"attachment-full size-full wp-image-4519\" alt=\"Logo Sobel White\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png 741w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White-300x117.png 300w\" sizes=\"(max-width: 741px) 100vw, 741px\" \/>\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-cfef7b5 elementor-align-left elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-button\" data-id=\"cfef7b5\" 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=\"#cta\">\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\">PARLEZ \u00c0 UN CONSULTANT<\/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-9128f96 e-flex e-con-boxed e-con e-parent\" data-id=\"9128f96\" 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-a3cad7b e-con-full e-flex e-con e-child\" data-id=\"a3cad7b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-75b60e8 elementor-widget elementor-widget-heading\" data-id=\"75b60e8\" 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 et BER pour les dispositifs m\u00e9dicaux<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-109e1f8 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"109e1f8\" 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<h1 class=\"elementor-heading-title elementor-size-default\">L'absence d'un BEP et d'un BER bien structur\u00e9s peut bloquer votre soumission \u00e0 la FDA !<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-75aad02 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"75aad02\" 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><span class=\"TextRun SCXW174199773 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW174199773 BCX0\">Planification et rapports d&rsquo;\u00e9valuation biologique pr\u00eats \u00e0 r\u00e9pondre aux exigences de la FDA.<\/span><\/span><span class=\"EOP SCXW174199773 BCX0\" data-ccp-props=\"{}\"> <\/span><\/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-9c68f3f elementor-align-left elementor-invisible elementor-widget elementor-widget-button\" data-id=\"9c68f3f\" 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=\"#cta\">\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\">PARLEZ \u00c0 UN CONSULTANT<\/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<div class=\"elementor-element elementor-element-583f716 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"583f716\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;,&quot;position&quot;:&quot;absolute&quot;,&quot;motion_fx_motion_fx_mouse&quot;:&quot;yes&quot;,&quot;motion_fx_tilt_effect&quot;:&quot;yes&quot;,&quot;motion_fx_tilt_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:1,&quot;sizes&quot;:[]},&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-44008d0 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"44008d0\" 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\">Align\u00e9 sur<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a261337 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"a261337\" 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\">  ISO 10993 et FDA<\/h3>\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-f26c63c e-flex e-con-boxed e-con e-parent\" data-id=\"f26c63c\" 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-7af2887 e-con-full e-flex e-con e-child\" data-id=\"7af2887\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6b1fd5c elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-widget elementor-widget-image\" data-id=\"6b1fd5c\" 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=\"2560\" height=\"1463\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-1-scaled.jpg\" class=\"attachment-full size-full wp-image-15575\" alt=\"Table with medical products. Hospital setting. Medical device registration.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-1-scaled.jpg 2560w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-1-300x171.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-1-1024x585.jpg 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-1-768x439.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-1-1536x878.jpg 1536w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-1-2048x1170.jpg 2048w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/>\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-b2bb574 e-transform elementor-widget elementor-widget-image\" data-id=\"b2bb574\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_transform_translateY_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:24,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&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_translateX_effect_mobile&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;:[]},&quot;_transform_translateY_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" 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=\"768\" height=\"1024\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-768x1024.jpg\" class=\"attachment-large size-large wp-image-15581\" alt=\"A woman holding a smartphone in one hand and a stethoscope in the other. She wears medical gloves and appears to be in a hospital setting. Regulatory Medical Device Consultancy.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-768x1024.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-225x300.jpg 225w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-1152x1536.jpg 1152w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-1536x2048.jpg 1536w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-scaled.jpg 1920w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/>\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<div class=\"elementor-element elementor-element-61a7237 e-con-full e-flex e-con e-child\" data-id=\"61a7237\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;position&quot;:&quot;absolute&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a4841ee elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"a4841ee\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"lnr lnr-warning\"><\/i>\t\t\t<\/div>\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-6f6bdb5 elementor-widget elementor-widget-heading\" data-id=\"6f6bdb5\" 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\">Le r\u00e8glement d'exemption par cat\u00e9gorie est essentiel pour les soumissions \u00e0 la FDA !<\/span>\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-3e6349e e-con-full e-flex e-con e-child\" data-id=\"3e6349e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bbf0f3d elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"bbf0f3d\" 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\">S\u00e9curit\u00e9 biologique prouv\u00e9e - sans d\u00e9lai  <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c79db08 elementor-widget elementor-widget-text-editor\" data-id=\"c79db08\" 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>Vous envisagez d&rsquo;enregistrer votre dispositif m\u00e9dical aupr\u00e8s de la FDA ? Avant d&rsquo;arriver sur le march\u00e9, votre produit doit subir une \u00e9valuation rigoureuse pour prouver sa s\u00e9curit\u00e9 biologique, avec le BEP et le BER ! <\/p><p>Alors que le plan d&rsquo;\u00e9valuation biologique (BEP) d\u00e9finit la strat\u00e9gie et les tests n\u00e9cessaires pour votre dispositif m\u00e9dical, le rapport d&rsquo;\u00e9valuation biologique (BER) rassemble les r\u00e9sultats et les conclusions qui prouvent la s\u00e9curit\u00e9 du produit.<\/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-d7eadf5 elementor-align-left elementor-invisible elementor-widget elementor-widget-button\" data-id=\"d7eadf5\" 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=\"#cta\">\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\">PARLEZ \u00c0 UN CONSULTANT<\/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-8654e00 e-flex e-con-boxed e-con e-parent\" data-id=\"8654e00\" 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-81f5ee1 elementor-widget elementor-widget-heading\" data-id=\"81f5ee1\" 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\">Qui a besoin d'un BEP et d'un BER ?<\/h2>\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-58378f7 e-flex e-con-boxed e-con e-parent\" data-id=\"58378f7\" 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-b41dbd1 e-con-full e-flex e-con e-child\" data-id=\"b41dbd1\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;sticky&quot;:&quot;top&quot;,&quot;sticky_offset&quot;:40,&quot;sticky_parent&quot;:&quot;yes&quot;,&quot;sticky_on&quot;:[&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet&quot;,&quot;mobile&quot;],&quot;sticky_effects_offset&quot;:0,&quot;sticky_anchor_link_offset&quot;:0}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-980fd8e elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"980fd8e\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Dispositifs en cours de d\u00e9veloppement :  <\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a0dfcd1 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"a0dfcd1\" 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><span class=\"TextRun SCXW116363311 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW116363311 BCX0\">Produits en phase de conception et de d\u00e9veloppement qui n\u00e9cessitent un plan d&rsquo;\u00e9valuation biologique structur\u00e9.<\/span><\/span><\/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-322ebe1 elementor-view-stacked elementor-shape-circle elementor-widget elementor-widget-icon\" data-id=\"322ebe1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"lnr lnr-checkmark-circle\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\n\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-f1adfac e-con-full e-flex e-con e-child\" data-id=\"f1adfac\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;sticky&quot;:&quot;top&quot;,&quot;sticky_offset&quot;:40,&quot;sticky_parent&quot;:&quot;yes&quot;,&quot;sticky_on&quot;:[&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet&quot;,&quot;mobile&quot;],&quot;sticky_effects_offset&quot;:0,&quot;sticky_anchor_link_offset&quot;:0}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a27d66c elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"a27d66c\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Dispositifs \u00e0 contact humain :<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c4fceb2 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"c4fceb2\" 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><span class=\"TextRun SCXW10311979 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10311979 BCX0\">Tous les dispositifs m\u00e9dicaux qui doivent <\/span><span class=\"NormalTextRun SCXW10311979 BCX0\">d\u00e9montrer<\/span><span class=\"NormalTextRun SCXW10311979 BCX0\"> une biocompatibilit\u00e9 robuste <\/span><span class=\"NormalTextRun SCXW10311979 BCX0\">conform\u00e9ment \u00e0 la norme<\/span><span class=\"NormalTextRun SCXW10311979 BCX0\"> ISO 10993 et aux directives de la FDA.<\/span><\/span><span class=\"EOP SCXW10311979 BCX0\" data-ccp-props=\"{}\"> <\/span><\/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-918319e elementor-view-stacked elementor-shape-circle elementor-widget elementor-widget-icon\" data-id=\"918319e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"lnr lnr-checkmark-circle\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\n\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-5098940 e-con-full e-flex e-con e-child\" data-id=\"5098940\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;sticky&quot;:&quot;top&quot;,&quot;sticky_offset&quot;:40,&quot;sticky_parent&quot;:&quot;yes&quot;,&quot;sticky_on&quot;:[&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet&quot;,&quot;mobile&quot;],&quot;sticky_effects_offset&quot;:0,&quot;sticky_anchor_link_offset&quot;:0}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2dec4bd elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"2dec4bd\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Fabricants \u00e9trangers :<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6ec41a2 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"6ec41a2\" 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><span class=\"TextRun SCXW89835770 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW89835770 BCX0\">Les entreprises situ\u00e9es en dehors des \u00c9tats-Unis qui ont besoin d&rsquo;une documentation appropri\u00e9e pour obtenir l&rsquo;autorisation ou l&rsquo;approbation de la FDA.<\/span><\/span><\/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-09f2f29 elementor-view-stacked elementor-shape-circle elementor-widget elementor-widget-icon\" data-id=\"09f2f29\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"lnr lnr-checkmark-circle\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\n\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-7348b62 e-con-full e-flex e-con e-child\" data-id=\"7348b62\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;sticky&quot;:&quot;top&quot;,&quot;sticky_offset&quot;:40,&quot;sticky_parent&quot;:&quot;yes&quot;,&quot;sticky_on&quot;:[&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet&quot;,&quot;mobile&quot;],&quot;sticky_effects_offset&quot;:0,&quot;sticky_anchor_link_offset&quot;:0}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-81427ff elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"81427ff\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Dispositifs d\u00e9j\u00e0 nettoy\u00e9s :<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b4c62a8 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"b4c62a8\" 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><span class=\"TextRun SCXW150355381 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW150355381 BCX0\">Produits d\u00e9j\u00e0 autoris\u00e9s par la FDA qui n\u00e9cessitent une \u00e9valuation biologique actualis\u00e9e ou compl\u00e9mentaire en raison de modifications de la conception, des mat\u00e9riaux ou de la fabrication.<\/span><\/span><\/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-c66873e elementor-view-stacked elementor-shape-circle elementor-widget elementor-widget-icon\" data-id=\"c66873e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"lnr lnr-checkmark-circle\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\n\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-d5518b4 e-con-full e-flex e-con e-child\" data-id=\"d5518b4\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;sticky&quot;:&quot;top&quot;,&quot;sticky_offset&quot;:40,&quot;sticky_parent&quot;:&quot;yes&quot;,&quot;sticky_on&quot;:[&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet&quot;,&quot;mobile&quot;],&quot;sticky_effects_offset&quot;:0,&quot;sticky_anchor_link_offset&quot;:0}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8eb3d73 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"8eb3d73\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Dispositifs en cours d'examen par la FDA :  <\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-885eafa elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"885eafa\" 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><span class=\"NormalTextRun SCXW101689595 BCX0\">Soumissions ayant fait l&rsquo;objet d&rsquo;une <\/span><span class=\"NormalTextRun SCXW101689595 BCX0\">d&rsquo;informations<\/span><span class=\"NormalTextRun SCXW101689595 BCX0\"> qui ont fait l&rsquo;objet d&rsquo;une demande d&rsquo;informations compl\u00e9mentaires et qui doivent fournir des preuves de leur s\u00e9curit\u00e9 biologique.<\/span><\/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-1dc2643 elementor-view-stacked elementor-shape-circle elementor-widget elementor-widget-icon\" data-id=\"1dc2643\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"lnr lnr-checkmark-circle\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-63ac2c0 e-flex e-con-boxed e-con e-parent\" data-id=\"63ac2c0\" 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-6c56801 elementor-widget elementor-widget-heading\" data-id=\"6c56801\" 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\">Votre dispositif m\u00e9dical en conformit\u00e9 avec la FDA et ISO 10993  <\/h2>\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-7d9d505 e-flex e-con-boxed e-con e-parent\" data-id=\"7d9d505\" 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-699f425 e-con-full e-flex e-con e-child\" data-id=\"699f425\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7cf27ed elementor-widget elementor-widget-image\" data-id=\"7cf27ed\" 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 loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"450\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img3-1-1024x576.jpg\" class=\"attachment-large size-large wp-image-15587\" alt=\"Medical office with a laptop showing results.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img3-1-1024x576.jpg 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img3-1-300x169.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img3-1-768x432.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img3-1-1536x864.jpg 1536w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img3-1-2048x1152.jpg 2048w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\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<div class=\"elementor-element elementor-element-da66af9 e-con-full e-flex e-con e-child\" data-id=\"da66af9\" 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-9f6fa47 elementor-pagination-type-bullets elementor-arrows-position-inside elementor-pagination-position-outside elementor-widget elementor-widget-n-carousel\" data-id=\"9f6fa47\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;carousel_items&quot;:[{&quot;slide_title&quot;:&quot;Slide #2&quot;,&quot;_id&quot;:&quot;790df4a&quot;},{&quot;slide_title&quot;:&quot;Slide #2&quot;,&quot;_id&quot;:&quot;cf7e92e&quot;},{&quot;slide_title&quot;:&quot;Slide #2&quot;,&quot;_id&quot;:&quot;5b43673&quot;},{&quot;slide_title&quot;:&quot;Slide #2&quot;,&quot;_id&quot;:&quot;24b469b&quot;},{&quot;slide_title&quot;:&quot;Slide #2&quot;,&quot;_id&quot;:&quot;c8b64e2&quot;},{&quot;slide_title&quot;:&quot;Slide #2&quot;,&quot;_id&quot;:&quot;204ddd4&quot;}],&quot;slides_to_show&quot;:&quot;1&quot;,&quot;slides_to_show_tablet&quot;:&quot;1&quot;,&quot;slides_to_show_mobile&quot;:&quot;1&quot;,&quot;autoplay&quot;:&quot;yes&quot;,&quot;autoplay_speed&quot;:5000,&quot;pause_on_hover&quot;:&quot;yes&quot;,&quot;pause_on_interaction&quot;:&quot;yes&quot;,&quot;infinite&quot;:&quot;yes&quot;,&quot;speed&quot;:500,&quot;offset_sides&quot;:&quot;none&quot;,&quot;arrows&quot;:&quot;yes&quot;,&quot;pagination&quot;:&quot;bullets&quot;,&quot;image_spacing_custom&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;image_spacing_custom_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;image_spacing_custom_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;image_spacing_custom_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-carousel.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-carousel swiper\" role=\"region\" aria-roledescription=\"carousel\" aria-label=\"Carousel\" dir=\"ltr\">\n\t\t\t<div class=\"swiper-wrapper\" aria-live=\"off\">\n\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"1\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"1 sur 6\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-8c23f19 e-flex e-con-boxed e-con e-child\" data-id=\"8c23f19\" 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-e69c85e elementor-widget elementor-widget-heading\" data-id=\"e69c85e\" 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<h6 class=\"elementor-heading-title elementor-size-default\">Dispositifs m\u00e9dicaux<\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ec66970 elementor-widget elementor-widget-heading\" data-id=\"ec66970\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Alignement r\u00e9glementaire :<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-649e22d elementor-widget elementor-widget-text-editor\" data-id=\"649e22d\" 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><span class=\"TextRun SCXW103168421 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW103168421 BCX0\">  Respect des directives de la FDA, de la norme ISO 10993 et des normes internationales.<\/span><\/span><\/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\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"2\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"2 sur 6\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4cf0bb8 e-flex e-con-boxed e-con e-child\" data-id=\"4cf0bb8\" 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-9c8db96 elementor-widget elementor-widget-heading\" data-id=\"9c8db96\" 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<h6 class=\"elementor-heading-title elementor-size-default\">Dispositifs m\u00e9dicaux<\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-20749de elementor-widget elementor-widget-heading\" data-id=\"20749de\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Le rapport co\u00fbt-efficacit\u00e9 :<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3262d51 elementor-widget elementor-widget-text-editor\" data-id=\"3262d51\" 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><span class=\"TextRun SCXW91963820 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91963820 BCX0\">Ne r\u00e9alisez que les tests n\u00e9cessaires, ce qui permet de r\u00e9duire les d\u00e9penses inutiles.<\/span><\/span><\/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\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"3\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"3 sur 6\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-911cbd0 e-flex e-con-boxed e-con e-child\" data-id=\"911cbd0\" 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-326f1d2 elementor-widget elementor-widget-heading\" data-id=\"326f1d2\" 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<h6 class=\"elementor-heading-title elementor-size-default\">Dispositifs m\u00e9dicaux<\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bc056e3 elementor-widget elementor-widget-heading\" data-id=\"bc056e3\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Des soumissions plus rapides :<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-329a637 elementor-widget elementor-widget-text-editor\" data-id=\"329a637\" 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><span class=\"TextRun SCXW102291138 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW102291138 BCX0\">Avec une documentation compl\u00e8te et pr\u00eate \u00e0 \u00eatre audit\u00e9e, votre processus d&rsquo;examen par la FDA est plus fluide.<\/span><\/span><\/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\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"4\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"4 sur 6\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-52818fb e-flex e-con-boxed e-con e-child\" data-id=\"52818fb\" 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-843749c elementor-widget elementor-widget-heading\" data-id=\"843749c\" 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<h6 class=\"elementor-heading-title elementor-size-default\">Dispositifs m\u00e9dicaux<\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-deaed61 elementor-widget elementor-widget-heading\" data-id=\"deaed61\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Approche scientifique :  <\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0c12aea elementor-widget elementor-widget-text-editor\" data-id=\"0c12aea\" 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><span class=\"TextRun SCXW47908148 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW47908148 BCX0\">Analyses documentaires, analyses chimiques et donn\u00e9es historiques pour justifier la s\u00e9curit\u00e9.<\/span><\/span><\/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\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"5\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"5 sur 6\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-472b9b2 e-flex e-con-boxed e-con e-child\" data-id=\"472b9b2\" 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-f1cbb77 elementor-widget elementor-widget-heading\" data-id=\"f1cbb77\" 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<h6 class=\"elementor-heading-title elementor-size-default\">Dispositifs m\u00e9dicaux<\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c255e8e elementor-widget elementor-widget-heading\" data-id=\"c255e8e\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Une strat\u00e9gie sur mesure :  <\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a928db3 elementor-widget elementor-widget-text-editor\" data-id=\"a928db3\" 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><span class=\"TextRun SCXW205039214 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW205039214 BCX0\">Chaque dispositif fait l&rsquo;objet d&rsquo;une \u00e9valuation biologique personnalis\u00e9e.<\/span><\/span><\/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\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"6\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"6 sur 6\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-dac7927 e-flex e-con-boxed e-con e-child\" data-id=\"dac7927\" 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-304b6e5 elementor-widget elementor-widget-heading\" data-id=\"304b6e5\" 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<h6 class=\"elementor-heading-title elementor-size-default\">Dispositifs m\u00e9dicaux<\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dcb1706 elementor-widget elementor-widget-heading\" data-id=\"dcb1706\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Soutien r\u00e9glementaire :<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0ed687c elementor-widget elementor-widget-text-editor\" data-id=\"0ed687c\" 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><span class=\"TextRun SCXW211808722 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW211808722 BCX0\">Si la FDA demande des \u00e9claircissements, nous sommes pr\u00eats \u00e0 y r\u00e9pondre.<\/span><\/span><span class=\"EOP SCXW211808722 BCX0\" data-ccp-props=\"{}\"> <\/span><\/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\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-swiper-button elementor-swiper-button-prev\" role=\"button\" tabindex=\"0\" aria-label=\"Pr\u00e9c\u00e9dent\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-eicon-chevron-left\" viewBox=\"0 0 1000 1000\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M646 125C629 125 613 133 604 142L308 442C296 454 292 471 292 487 292 504 296 521 308 533L604 854C617 867 629 875 646 875 663 875 679 871 692 858 704 846 713 829 713 812 713 796 708 779 692 767L438 487 692 225C700 217 708 204 708 187 708 171 704 154 692 142 675 129 663 125 646 125Z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t\t<div class=\"elementor-swiper-button elementor-swiper-button-next\" role=\"button\" tabindex=\"0\" aria-label=\"Suivant\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-eicon-chevron-right\" viewBox=\"0 0 1000 1000\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M696 533C708 521 713 504 713 487 713 471 708 454 696 446L400 146C388 133 375 125 354 125 338 125 325 129 313 142 300 154 292 171 292 187 292 204 296 221 308 233L563 492 304 771C292 783 288 800 288 817 288 833 296 850 308 863 321 871 338 875 354 875 371 875 388 867 400 854L696 533Z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t\t\t\t<div class=\"swiper-pagination\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ec27ade e-flex e-con-boxed e-con e-parent\" data-id=\"ec27ade\" 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-2a2574e elementor-align-left elementor-invisible elementor-widget elementor-widget-button\" data-id=\"2a2574e\" 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=\"#cta\">\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\">PARLEZ \u00c0 UN CONSULTANT<\/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-8ddd0b0 e-flex e-con-boxed e-con e-parent\" data-id=\"8ddd0b0\" data-element_type=\"container\" data-e-type=\"container\" id=\"cta\" 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-c56823a e-con-full e-flex e-con e-child\" data-id=\"c56823a\" 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-1ac18ca elementor-align-center elementor-widget elementor-widget-lottie\" data-id=\"1ac18ca\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;source_json&quot;:{&quot;url&quot;:&quot;https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2025\\\/10\\\/Contact-us.json&quot;,&quot;id&quot;:16710,&quot;size&quot;:&quot;&quot;,&quot;alt&quot;:&quot;&quot;,&quot;source&quot;:&quot;library&quot;},&quot;loop&quot;:&quot;yes&quot;,&quot;source&quot;:&quot;media_file&quot;,&quot;caption_source&quot;:&quot;none&quot;,&quot;link_to&quot;:&quot;none&quot;,&quot;trigger&quot;:&quot;arriving_to_viewport&quot;,&quot;viewport&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:0,&quot;end&quot;:100}},&quot;play_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:1,&quot;sizes&quot;:[]},&quot;start_point&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;end_point&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:100,&quot;sizes&quot;:[]},&quot;renderer&quot;:&quot;svg&quot;}\" data-widget_type=\"lottie.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"e-lottie__container\"><div class=\"e-lottie__animation\"><\/div><\/div>\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-fa49004 e-con-full e-flex e-con e-child\" data-id=\"fa49004\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6cc5b91 elementor-widget elementor-widget-heading\" data-id=\"6cc5b91\" 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<h1 class=\"elementor-heading-title elementor-size-default\">Contactez nous<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4b2503b elementor-widget elementor-widget-heading\" data-id=\"4b2503b\" 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<p class=\"elementor-heading-title elementor-size-default\">Nous serions ravis de parler avec vous.<br>N'h\u00e9sitez pas \u00e0 nous contacter en utilisant les coordonn\u00e9es ci-dessous.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8a61ad5 elementor-widget__width-initial elementor-button-align-stretch elementor-widget elementor-widget-form\" data-id=\"8a61ad5\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;step_next_label&quot;:&quot;Suivant&quot;,&quot;step_previous_label&quot;:&quot;Pr\\u00e9c\\u00e9dent&quot;,&quot;button_width&quot;:&quot;100&quot;,&quot;step_type&quot;:&quot;number_text&quot;,&quot;step_icon_shape&quot;:&quot;circle&quot;}\" data-widget_type=\"form.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<form class=\"elementor-form\" method=\"post\" id=\"form_bepber_eng\" name=\"FORM LP MD (BEP\/BER) ENG\" aria-label=\"FORM LP MD (BEP\/BER) ENG\">\n\t\t\t<input type=\"hidden\" name=\"post_id\" value=\"15974\"\/>\n\t\t\t<input type=\"hidden\" name=\"form_id\" value=\"8a61ad5\"\/>\n\t\t\t<input type=\"hidden\" name=\"referer_title\" value=\"Sobel\" \/>\n\n\t\t\t\n\t\t\t<div class=\"elementor-form-fields-wrapper elementor-labels-above\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-first_name elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-first_name\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tNom complet\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[first_name]\" id=\"form-field-first_name\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Tapez ici\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-email elementor-field-group elementor-column elementor-field-group-email elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-email\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tAdresse \u00e9lectronique\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"email\" name=\"form_fields[email]\" id=\"form-field-email\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Tapez ici\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-tel elementor-field-group elementor-column elementor-field-group-phone elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-phone\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tNum\u00e9ro de t\u00e9l\u00e9phone\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t<input size=\"1\" type=\"tel\" name=\"form_fields[phone]\" id=\"form-field-phone\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Tapez ici\" required=\"required\" pattern=\"[0-9()#&amp;+*-=.]+\" title=\"Seuls les caract\u00e8res de num\u00e9ros de t\u00e9l\u00e9phone (#, -, *, etc.) sont accept\u00e9s.\">\n\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-company elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-company\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tEntreprise\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[company]\" id=\"form-field-company\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Tapez ici\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-textarea elementor-field-group elementor-column elementor-field-group-message elementor-col-100 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-message\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tMessage\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t<textarea class=\"elementor-field-textual elementor-field  elementor-size-sm\" name=\"form_fields[message]\" id=\"form-field-message\" rows=\"4\" placeholder=\"Tapez ici\" required=\"required\"><\/textarea>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-acceptance elementor-field-group elementor-column elementor-field-group-privacyagreed elementor-col-100 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t<div class=\"elementor-field-subgroup\">\n\t\t\t<span class=\"elementor-field-option\">\n\t\t\t\t<input type=\"checkbox\" name=\"form_fields[privacyagreed]\" id=\"form-field-privacyagreed\" class=\"elementor-field elementor-size-sm  elementor-acceptance-field\" required=\"required\">\n\t\t\t\t<label for=\"form-field-privacyagreed\">&nbsp;&nbsp;  J'accepte la d\u00e9claration de confidentialit\u00e9 des donn\u00e9es et les conditions g\u00e9n\u00e9rales publi\u00e9es sur ce site.<\/label>\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-acceptance elementor-field-group elementor-column elementor-field-group-newslettercheck elementor-col-100\">\n\t\t\t\t\t\t\t<div class=\"elementor-field-subgroup\">\n\t\t\t<span class=\"elementor-field-option\">\n\t\t\t\t<input type=\"checkbox\" name=\"form_fields[newslettercheck]\" id=\"form-field-newslettercheck\" class=\"elementor-field elementor-size-sm  elementor-acceptance-field\">\n\t\t\t\t<label for=\"form-field-newslettercheck\">&nbsp; &nbsp;J'accepte de recevoir des bulletins d'information bihebdomadaires contenant des mises \u00e0 jour sur le march\u00e9 r\u00e9glementaire mondial.<\/label>\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_source elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_source]\" id=\"form-field-utm_source\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_campaign elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_campaign]\" id=\"form-field-utm_campaign\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_adgroupname elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_adgroupname]\" id=\"form-field-utm_adgroupname\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_term elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_term]\" id=\"form-field-utm_term\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-gclid elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[gclid]\" id=\"form-field-gclid\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_content elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_content]\" id=\"form-field-utm_content\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_device elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_device]\" id=\"form-field-utm_device\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-group elementor-column elementor-field-type-submit elementor-col-100 e-form__buttons\">\n\t\t\t\t\t<button class=\"elementor-button elementor-size-sm\" type=\"submit\" id=\"contact_btn_bepber_eng\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Soumettre<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/button>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/form>\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-e6fe964 elementor-widget elementor-widget-html\" data-id=\"e6fe964\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<link data-minify=\"1\" rel=\"stylesheet\" href=\"https:\/\/ciparoni.com\/wp-content\/cache\/background-css\/1\/ciparoni.com\/wp-content\/cache\/min\/1\/ajax\/libs\/intl-tel-input\/17.0.8\/css\/intlTelInput.css?ver=1760368402&amp;wpr_t=1760357602\">\r\n\r\n<script data-minify=\"1\" src=\"https:\/\/ciparoni.com\/wp-content\/cache\/min\/1\/ajax\/libs\/intl-tel-input\/17.0.8\/js\/intlTelInput.min.js?ver=1760368402\"><\/script>\r\n\r\n<script data-minify=\"1\" src=\"https:\/\/ciparoni.com\/wp-content\/cache\/min\/1\/ajax\/libs\/jquery\/3.7.1\/jquery.min.js?ver=1760368402\"><\/script>\r\n\r\n<script>\r\n    const phoneInputField = document.querySelectorAll('input[type=\"tel\"]');\r\n    const btForm = document.querySelectorAll('.elementor-button[type=\"submit\"]');\r\n    let telefones = [];\r\n\r\n    for (i = 0; i < phoneInputField.length; i++){\r\n        var phone_number = window.intlTelInput(phoneInputField[i], {\r\n        separateDialCode: true,\r\n        preferredCountries:[\"br\",\"us\", \"de\", \"fr\" ],\r\n        hiddenInput: \"full\",\r\n        utilsScript: \"\/\/cdnjs.cloudflare.com\/ajax\/libs\/intl-tel-input\/17.0.8\/js\/utils.js\"\r\n        });\r\n\r\n        telefones[i] = phone_number;\r\n    }\r\n    $(phoneInputField).each(function(i) {\r\n        $(\"form\").submit(function() {\r\n            var full_number = telefones[i].getNumber(intlTelInputUtils.numberFormat.E164);\r\n            $(phoneInputField[i]).val(full_number);\r\n            console.log(phoneInputField[i]);\r\n            console.log(phone_number);\r\n        });\r\n    });\r\n\r\n    for (i = 0; i < phoneInputField.length; i++){\r\n        var larguraInput = phoneInputField[i].getBoundingClientRect().width;\r\n        $(\".iti__country-list\").css({width: larguraInput});\r\n    }\r\n\r\n    window.addEventListener(\"resize\", function() {\r\n      for (let i = 0; i < phoneInputField.length; i++) {\r\n        const larguraInput = phoneInputField[i].offsetWidth;\r\n        $(\".iti__country-list\").css({ width: larguraInput });\r\n      }\r\n  });\r\n<\/script>\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-eae664a e-flex e-con-boxed e-con e-parent\" data-id=\"eae664a\" 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-259162b elementor-widget elementor-widget-heading\" data-id=\"259162b\" 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\">FAQ<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-901610b elementor-widget elementor-widget-toggle\" data-id=\"901610b\" 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-1511\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1511\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Ai-je vraiment besoin d'un BEP et d'un BER pour la soumission \u00e0 la FDA ?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1511\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1511\"><p><span class=\"NormalTextRun SCXW2684963 BCX0\">La FDA n&rsquo;exige pas formellement <\/span><span class=\"NormalTextRun SCXW2684963 BCX0\">formellement<\/span><span class=\"NormalTextRun SCXW2684963 BCX0\">  Ces documents sont appel\u00e9s \u00ab\u00a0BEP\u00a0\u00bb ou \u00ab\u00a0BER\u00a0\u00bb. Cependant, un plan d&rsquo;\u00e9valuation biologique est fortement recommand\u00e9 pour d\u00e9finir votre strat\u00e9gie d&rsquo;essai, et un rapport d&rsquo;\u00e9valuation biologique (\u00e9galement connu sous le nom de rapport d&rsquo;\u00e9valuation de la s\u00e9curit\u00e9 biologique) est essentiel pour   <\/span><span class=\"NormalTextRun SCXW2684963 BCX0\">consolider<\/span><span class=\"NormalTextRun SCXW2684963 BCX0\"> les preuves <\/span><span class=\"NormalTextRun SCXW2684963 BCX0\">n\u00e9cessaires<\/span><span class=\"NormalTextRun SCXW2684963 BCX0\"> pour l&rsquo;examen de la FDA.<\/span><\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1512\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-1512\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Une \u00e9valuation biologique ne risque-t-elle pas de retarder l'autorisation ou l'approbation de la FDA ?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1512\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-1512\"><p><span class=\"TextRun SCXW110282234 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW110282234 BCX0\">Au contraire, une MPE et un TEB bien pr\u00e9par\u00e9s <\/span><span class=\"NormalTextRun AdvancedProofingIssueV2Themed SCXW110282234 BCX0\">acc\u00e9l\u00e8rent en fait<\/span><span class=\"NormalTextRun SCXW110282234 BCX0\"> le <\/span><span class=\"NormalTextRun SCXW110282234 BCX0\">processus, car<\/span><span class=\"NormalTextRun SCXW110282234 BCX0\"> ils minimisent le risque de questions de la FDA ou de <\/span><span class=\"NormalTextRun SCXW110282234 BCX0\">d&rsquo;informations<\/span><span class=\"NormalTextRun SCXW110282234 BCX0\"> d&rsquo;informations suppl\u00e9mentaires (AI).<\/span><\/span><span class=\"EOP SCXW110282234 BCX0\" data-ccp-props=\"{}\"> <\/span><\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1513\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-1513\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Puis-je utiliser la litt\u00e9rature scientifique au lieu d'effectuer tous les tests ?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1513\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-1513\"><p><span class=\"NormalTextRun SCXW3233987 BCX0\">Oui. Les orientations de la FDA align\u00e9es sur la norme ISO 10993 autorisent l&rsquo;utilisation de la litt\u00e9rature scientifique, de l&rsquo;utilisation historique et des produits chimiques.   <\/span><span class=\"NormalTextRun SCXW3233987 BCX0\">caract\u00e9risation<\/span><span class=\"NormalTextRun SCXW3233987 BCX0\"> pour justifier la s\u00e9curit\u00e9 biologique, le cas \u00e9ch\u00e9ant <\/span><span class=\"NormalTextRun SCXW3233987 BCX0\">le cas \u00e9ch\u00e9ant<\/span><span class=\"NormalTextRun SCXW3233987 BCX0\">. Nous  <\/span><span class=\"NormalTextRun SCXW3233987 BCX0\">\u00e9tablir des priorit\u00e9s<\/span><span class=\"NormalTextRun SCXW3233987 BCX0\"> une approche bas\u00e9e sur le risque qui \u00e9vite les tests inutiles.<\/span><\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1514\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-1514\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Puis-je utiliser des rapports internationaux d\u00e9j\u00e0 pr\u00e9par\u00e9s ?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1514\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-1514\"><p><span class=\"TextRun SCXW223156773 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW223156773 BCX0\">Cela d\u00e9pend. La FDA peut accepter des donn\u00e9es internationales si elles sont conformes \u00e0 la norme ISO 10993 et aux directives de la FDA. Toutefois, les documents doivent souvent \u00eatre reformat\u00e9s ou compl\u00e9t\u00e9s pour r\u00e9pondre aux exigences de la FDA.  <\/span><\/span><\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1515\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-1515\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Je dispose d\u00e9j\u00e0 de tests toxicologiques. Est-ce suffisant pour une soumission \u00e0 la FDA ? <\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1515\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-1515\"><p><span class=\"NormalTextRun SCXW208746180 BCX0\">Non. Les rapports d&rsquo;essais isol\u00e9s ne sont pas suffisants. Un rapport d&rsquo;\u00e9valuation biologique complet est    <\/span><span class=\"NormalTextRun SCXW208746180 BCX0\">n\u00e9cessaire<\/span><span class=\"NormalTextRun SCXW208746180 BCX0\"> pour int\u00e9grer les donn\u00e9es toxicologiques, l&rsquo;analyse des risques et la justification scientifique dans le contexte de votre dispositif sp\u00e9cifique.<\/span><\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1516\" class=\"elementor-tab-title\" data-tab=\"6\" role=\"button\" aria-controls=\"elementor-tab-content-1516\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Que se passe-t-il si je n'ai pas effectu\u00e9 tous les tests ?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1516\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"6\" role=\"region\" aria-labelledby=\"elementor-tab-title-1516\"><p><span class=\"NormalTextRun SCXW168493695 BCX0\">Il s&rsquo;agit d&rsquo;une pratique courante. Un plan d&rsquo;\u00e9valuation biologique montre quelles donn\u00e9es peuvent d\u00e9j\u00e0 \u00eatre utilis\u00e9es et quelles sont les lacunes   <\/span><span class=\"NormalTextRun SCXW168493695 BCX0\">rester<\/span><span class=\"NormalTextRun SCXW168493695 BCX0\">. Dans de nombreux cas, nous pouvons fournir une justification scientifique permettant de renoncer \u00e0 des tests inutiles.<\/span><\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1517\" class=\"elementor-tab-title\" data-tab=\"7\" role=\"button\" aria-controls=\"elementor-tab-content-1517\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Combien de temps faut-il pour pr\u00e9parer un BEP et un BER pour la FDA ?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1517\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"7\" role=\"region\" aria-labelledby=\"elementor-tab-title-1517\"><p><span class=\"TextRun SCXW232582825 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232582825 BCX0\">Le calendrier d\u00e9pend de la complexit\u00e9 du dispositif et de la disponibilit\u00e9 des donn\u00e9es existantes. Gr\u00e2ce \u00e0 une documentation organis\u00e9e, nous fournissons un calendrier pr\u00e9cis adapt\u00e9 \u00e0 votre voie de soumission \u00e0 la FDA (par exemple, 510(k), PMA, De Novo). <\/span><\/span><\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1518\" class=\"elementor-tab-title\" data-tab=\"8\" role=\"button\" aria-controls=\"elementor-tab-content-1518\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Que faire si j'ai d\u00e9j\u00e0 un rapport, mais que je ne suis pas s\u00fbr que la FDA l'acceptera ?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1518\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"8\" role=\"region\" aria-labelledby=\"elementor-tab-title-1518\"><p><span class=\"TextRun SCXW121833878 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW121833878 BCX0\">Nous pouvons proc\u00e9der \u00e0 un examen critique de votre rapport, en l&rsquo;adaptant aux exigences de la FDA et en augmentant les chances d&rsquo;acceptation sans retouches co\u00fbteuses.<\/span><\/span><span class=\"EOP SCXW121833878 BCX0\" data-ccp-props=\"{}\"> <\/span><\/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<div class=\"elementor-element elementor-element-4c38712 e-flex e-con-boxed e-con e-parent\" data-id=\"4c38712\" 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-ec6877d elementor-widget elementor-widget-theme-site-logo elementor-widget-image\" data-id=\"ec6877d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-site-logo.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"741\" height=\"290\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png\" class=\"attachment-full size-full wp-image-4519\" alt=\"Logo Sobel White\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png 741w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White-300x117.png 300w\" sizes=\"(max-width: 741px) 100vw, 741px\" \/>\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-6bfceb9 elementor-widget elementor-widget-heading\" data-id=\"6bfceb9\" 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\"><a href=\"https:\/\/sobelconsult.com\/fr\/declaration-de-confidentialite-us\/\" target=\"_blank\">Politique de confidentialit\u00e9<\/a><\/span>\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>PARLEZ \u00c0 UN CONSULTANT BEP et BER pour les dispositifs m\u00e9dicaux L&rsquo;absence d&rsquo;un BEP et d&rsquo;un BER bien structur\u00e9s peut bloquer votre soumission \u00e0 la FDA ! Planification et rapports d&rsquo;\u00e9valuation biologique pr\u00eats \u00e0 r\u00e9pondre aux exigences de la FDA. PARLEZ \u00c0 UN CONSULTANT Align\u00e9 sur ISO 10993 et FDA Le r\u00e8glement d&rsquo;exemption par cat\u00e9gorie [&hellip;]<\/p>\n","protected":false},"author":16,"featured_media":0,"parent":15869,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_canvas","meta":{"footnotes":""},"class_list":["post-15974","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>\u00c9valuation biologique pour les dispositifs m\u00e9dicaux de la FDA | BEP &amp; BER<\/title>\n<meta name=\"description\" content=\"Garantissez la conformit\u00e9 avec la FDA gr\u00e2ce \u00e0 une \u00e9valuation biologique compl\u00e8te. 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