{"id":8823,"date":"2025-06-01T10:00:00","date_gmt":"2025-06-01T13:00:00","guid":{"rendered":"https:\/\/sobelconsult.com\/md-ue-formation\/"},"modified":"2026-02-18T08:58:28","modified_gmt":"2026-02-18T11:58:28","slug":"european-regulatory-affairs-training","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/fr\/our-solutions-europe\/european-regulatory-affairs-training\/","title":{"rendered":"MD - UE - Formation"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"8823\" class=\"elementor elementor-8823 elementor-8818\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8206a77 e-flex e-con-boxed e-con e-parent\" data-id=\"8206a77\" 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-e3e0d9c elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"e3e0d9c\" 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\">Formation aux affaires r\u00e9glementaires europ\u00e9ennes  <\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2cd8249 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"2cd8249\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"From CE Marking to post-market obligations, regulatory knowledge plays a critical role in maintaining compliance. Sobel prepares regulatory teams through structured European regulatory affairs training, designed to build practical understanding, strengthen internal capabilities, and enable confident decision-making.\"}]\" data-inline-monday=\"true\">Du marquage CE aux obligations post-commercialisation, les connaissances r\u00e9glementaires jouent un r\u00f4le essentiel dans le maintien de la conformit\u00e9. Sobel pr\u00e9pare les \u00e9quipes r\u00e9glementaires par le biais d&rsquo;une formation structur\u00e9e aux affaires r\u00e9glementaires europ\u00e9ennes pour les dispositifs m\u00e9dicaux, con\u00e7ue pour d\u00e9velopper une compr\u00e9hension pratique, renforcer les capacit\u00e9s internes et permettre une prise de d\u00e9cision en toute confiance. <\/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-2c4a4dc elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"2c4a4dc\" 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-47ca243 e-flex e-con-boxed e-con e-parent\" data-id=\"47ca243\" 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-765c7a8 e-con-full e-flex e-con e-child\" data-id=\"765c7a8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-b80d131 e-con-full e-transform e-flex e-con e-child\" data-id=\"b80d131\" 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-0fcdc38 elementor-widget elementor-widget-heading\" data-id=\"0fcdc38\" 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-74fe778 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"74fe778\" 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-03b7d6f elementor-align-end elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"03b7d6f\" 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 entreprises qui se pr\u00e9parent \u00e0 se conformer \u00e0 la r\u00e9glementation europ\u00e9enne sur les dispositifs m\u00e9dicaux ou qui s'y conforment<\/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\">Fabricants et importateurs soumis aux exigences du marquage CE<\/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 \u00e9quipes RA\/QA \u00e0 la recherche d'une formation structur\u00e9e et pratique sur les affaires r\u00e9glementaires europ\u00e9ennes<\/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\">Professionnels responsables des soumissions r\u00e9glementaires et des activit\u00e9s post-commercialisation<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Organisations cherchant \u00e0 renforcer les connaissances r\u00e9glementaires internes au sein des \u00e9quipes<\/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-d9f1775 e-con-full e-flex e-con e-child\" data-id=\"d9f1775\" 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-a0053ef elementor-widget elementor-widget-image\" data-id=\"a0053ef\" 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-cb97a1b e-flex e-con-boxed e-con e-parent\" data-id=\"cb97a1b\" 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-088ccee elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"088ccee\" 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 delivers European regulatory affairs training designed to build practical understanding, regulatory confidence, and internal capability. \"}]\" data-inline-monday=\"true\">Sobel dispense des formations sur les affaires r\u00e9glementaires europ\u00e9ennes con\u00e7ues pour renforcer la compr\u00e9hension pratique, la confiance dans les r\u00e9glementations et les capacit\u00e9s internes.  <\/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-755aa56 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"755aa56\" 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-ba64f30 e-flex e-con-boxed e-con e-parent\" data-id=\"ba64f30\" 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-4b71757 elementor-widget-mobile__width-inherit elementor-widget elementor-widget-image\" data-id=\"4b71757\" 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-84a59ee elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"84a59ee\" 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-cee7000 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"cee7000\" 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-e4f6095 e-con-full e-flex e-con e-child\" data-id=\"e4f6095\" 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-24f0f81 elementor-widget elementor-widget-text-editor\" data-id=\"24f0f81\" 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\":\"European regulatory affairs training helps teams interpret complex regulations and apply them correctly in practice.\"}]\" data-inline-monday=\"true\">La formation europ\u00e9enne aux affaires r\u00e9glementaires aide les \u00e9quipes \u00e0 interpr\u00e9ter les r\u00e9glementations complexes et \u00e0 les appliquer correctement dans la pratique.<\/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-d5890a2 e-con-full e-flex e-con e-child\" data-id=\"d5890a2\" 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-6a567b3 elementor-widget elementor-widget-text-editor\" data-id=\"6a567b3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Well-trained teams reduce compliance risks, avoid rework, and make better regulatory decisions.\"}]\" data-inline-monday=\"true\">Des \u00e9quipes bien form\u00e9es r\u00e9duisent les risques li\u00e9s \u00e0 la conformit\u00e9, \u00e9vitent les retouches et prennent de meilleures d\u00e9cisions en mati\u00e8re de r\u00e9glementation.<\/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-04aeb17 e-con-full e-flex e-con e-child\" data-id=\"04aeb17\" 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-519d4a7 elementor-widget elementor-widget-text-editor\" data-id=\"519d4a7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Regulatory knowledge empowers internal teams to manage registrations, post-market activities, and interactions with Notified Bodies more effectively.\"}]\" data-inline-monday=\"true\">Les connaissances r\u00e9glementaires permettent aux \u00e9quipes internes de g\u00e9rer plus efficacement les enregistrements, les activit\u00e9s post-commercialisation et les interactions avec les organismes notifi\u00e9s.<\/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-f0ca088 e-flex e-con-boxed e-con e-parent\" data-id=\"f0ca088\" 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-9b6e9ba e-con-full e-flex e-con e-child\" data-id=\"9b6e9ba\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2e82048 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"2e82048\" 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\">D\u00e9velopper les connaissances r\u00e9glementaires pour le march\u00e9 europ\u00e9en<\/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-c16f4ce e-con-full e-flex e-con e-child\" data-id=\"c16f4ce\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f2a9d43 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"f2a9d43\" 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>La formation aux affaires r\u00e9glementaires europ\u00e9ennes soutient les entreprises op\u00e9rant dans le cadre du MDR 2017\/745 de l&rsquo;UE et du MDR du Royaume-Uni en renfor\u00e7ant l&rsquo;interpr\u00e9tation r\u00e9glementaire, la compr\u00e9hension de la documentation technique et la pr\u00e9paration \u00e0 la conformit\u00e9 apr\u00e8s la mise sur le march\u00e9.<\/p><p><strong>  Une formation r\u00e9glementaire structur\u00e9e aide les \u00e9quipes \u00e0 appliquer les exigences r\u00e9glementaires de mani\u00e8re coh\u00e9rente dans les activit\u00e9s de d\u00e9veloppement de produits, de certification et de gestion du cycle de vie.<\/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-220d17f e-flex e-con-boxed e-con e-parent\" data-id=\"220d17f\" 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-0dbdf40 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"0dbdf40\" 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\">D\u00e9velopper les comp\u00e9tences r\u00e9glementaires n\u00e9cessaires pour prendre des d\u00e9cisions en toute confiance en Europe.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eae40b8 elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"eae40b8\" 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_eae40b8 *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_eae40b8{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_eae40b8 .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_eae40b8  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_eae40b8  .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_eae40b8 .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .ue-item-bullet i, #uc_horizontal_timeline_elementor_eae40b8 .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_eae40b8 .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_eae40b8 .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_eae40b8\">\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_eae40b8\" data-custom-sethtml=\"true\"  >\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=\"#\" >Choisissez votre programme de formation<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">S\u00e9lectionnez la formation r\u00e9glementaire qui correspond le mieux au r\u00f4le, au niveau d'exp\u00e9rience et aux responsabilit\u00e9s r\u00e9glementaires de votre \u00e9quipe.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-8ddbe50\">\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\u00e9finir le format<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Les formations peuvent \u00eatre dispens\u00e9es en ligne ou sur place, en fonction de la localisation et des pr\u00e9f\u00e9rences de votre \u00e9quipe.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-fea32bd\">\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=\"#\" >Participez \u00e0 des sessions dirig\u00e9es par des experts<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Votre \u00e9quipe participe \u00e0 des sessions structur\u00e9es ax\u00e9es sur la compr\u00e9hension pratique de la r\u00e9glementation et sur des sc\u00e9narios r\u00e9els.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-d826337\">\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=\"#\" >Renforcer les capacit\u00e9s internes<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Les participants terminent la formation avec une plus grande confiance en mati\u00e8re de r\u00e9glementation et une meilleure compr\u00e9hension de leurs responsabilit\u00e9s.<\/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-94d20ae elementor-align-center elementor-widget elementor-widget-button\" data-id=\"94d20ae\" 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-b69b44e animated-slow e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"b69b44e\" 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-40da2a2 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"40da2a2\" 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\">Nos programmes de formation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6a3b5f3 elementor-widget elementor-widget-text-editor\" data-id=\"6a3b5f3\" 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\":\"Our european regulatory affairs training programs are available in different modalities, depending on your regulatory focus, device portfolio, and team responsibilities.\"}]\" data-inline-monday=\"true\">Nos programmes de formation aux affaires r\u00e9glementaires europ\u00e9ennes sont disponibles sous diff\u00e9rentes formes, en fonction de vos objectifs r\u00e9glementaires, de votre portefeuille de dispositifs et des responsabilit\u00e9s de votre \u00e9quipe.<\/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-f54ac19 e-con-full e-flex e-con e-child\" data-id=\"f54ac19\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-7a0f5a2 e-con-full e-flex e-con e-child\" data-id=\"7a0f5a2\" 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-33873a5 elementor-widget elementor-widget-heading\" data-id=\"33873a5\" 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\">Marquage CE - L'essentiel<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6840904 elementor-widget elementor-widget-text-editor\" data-id=\"6840904\" 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\":\"This training is designed for professionals who need a clear and structured introduction to the CE Marking process for medical devices in Europe. It provides an overview of the European regulatory environment and explains how medical devices move from classification to certification and post-market responsibilities. \"}]\" data-inline-monday=\"true\">Cette formation est destin\u00e9e aux professionnels qui ont besoin d&rsquo;une introduction claire et structur\u00e9e au processus de marquage CE pour les dispositifs m\u00e9dicaux en Europe. Elle donne un aper\u00e7u de l&rsquo;environnement r\u00e9glementaire europ\u00e9en et explique comment les dispositifs m\u00e9dicaux passent de la classification \u00e0 la certification et aux responsabilit\u00e9s apr\u00e8s la mise sur le march\u00e9. <\/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-48fe7ab e-con-full e-flex e-con e-child\" data-id=\"48fe7ab\" 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-6cebe69 elementor-widget elementor-widget-heading\" data-id=\"6cebe69\" 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\">Marquage CE - Avanc\u00e9 : Naviguer dans la conformit\u00e9 et au-del\u00e0<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9661cf6 elementor-widget elementor-widget-text-editor\" data-id=\"9661cf6\" 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\":\"This advanced training supports professionals who already work with CE Marking and need deeper regulatory insight. The training explores complex compliance scenarios, technical documentation expectations, conformity assessment strategies, and post-market obligations. It is especially suited for teams managing higher-risk devices or facing more demanding regulatory interactions.\"}]\" data-inline-monday=\"true\">Cette formation avanc\u00e9e s&rsquo;adresse aux professionnels qui travaillent d\u00e9j\u00e0 avec le marquage CE et qui ont besoin d&rsquo;une connaissance plus approfondie de la r\u00e9glementation. La formation explore des sc\u00e9narios de conformit\u00e9 complexes, les attentes en mati\u00e8re de documentation technique, les strat\u00e9gies d&rsquo;\u00e9valuation de la conformit\u00e9 et les obligations post-commercialisation. Elle est particuli\u00e8rement adapt\u00e9e aux \u00e9quipes qui g\u00e8rent des dispositifs \u00e0 haut risque ou qui sont confront\u00e9es \u00e0 des interactions r\u00e9glementaires plus exigeantes.  <\/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-ee1decf e-con-full e-flex e-con e-child\" data-id=\"ee1decf\" 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-2133016 elementor-widget elementor-widget-heading\" data-id=\"2133016\" 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\">PRRC (Personne responsable de la conformit\u00e9 r\u00e9glementaire)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7a00cd6 elementor-widget elementor-widget-text-editor\" data-id=\"7a00cd6\" 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\":\"Focused on the role of the Person Responsible for Regulatory Compliance, this training addresses the specific responsibilities assigned under European legislation. It helps participants understand how the PRRC role fits within the broader regulatory framework, how it interacts with quality systems and post-market activities, and how to approach regulatory responsibilities in a structured and compliant manner.\"}]\" data-inline-monday=\"true\">Ax\u00e9e sur le r\u00f4le de la personne responsable de la conformit\u00e9 r\u00e9glementaire, cette formation aborde les responsabilit\u00e9s sp\u00e9cifiques attribu\u00e9es par la l\u00e9gislation europ\u00e9enne. Elle aide les participants \u00e0 comprendre comment le r\u00f4le du PRRC s&rsquo;inscrit dans le cadre r\u00e9glementaire g\u00e9n\u00e9ral, comment il interagit avec les syst\u00e8mes de qualit\u00e9 et les activit\u00e9s post-commercialisation, et comment aborder les responsabilit\u00e9s r\u00e9glementaires d&rsquo;une mani\u00e8re structur\u00e9e et conforme. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a010168 e-con-full e-flex e-con e-child\" data-id=\"a010168\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-388da5d e-con-full e-flex e-con e-child\" data-id=\"388da5d\" 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-34e37d5 elementor-widget elementor-widget-heading\" data-id=\"34e37d5\" 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\">ISO 14971 - Gestion des risques 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-e48873d elementor-widget elementor-widget-text-editor\" data-id=\"e48873d\" 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\":\"This training provides a practical understanding of risk management as applied to medical devices throughout their lifecycle. Based on ISO 14971, the course explains how risk management supports regulatory compliance, product safety, and decision-making from development to post-production. \"}]\" data-inline-monday=\"true\">Cette formation offre une compr\u00e9hension pratique de la gestion des risques appliqu\u00e9e aux dispositifs m\u00e9dicaux tout au long de leur cycle de vie. Bas\u00e9 sur la norme ISO 14971, le cours explique comment la gestion des risques soutient la conformit\u00e9 r\u00e9glementaire, la s\u00e9curit\u00e9 des produits et la prise de d\u00e9cision depuis le d\u00e9veloppement jusqu&rsquo;\u00e0 la post-production. <\/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-8ba126b e-con-full e-flex e-con e-child\" data-id=\"8ba126b\" 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-c78f5f5 elementor-widget elementor-widget-heading\" data-id=\"c78f5f5\" 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\">MDR 2017\/745 - R\u00e8glement relatif aux 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-8215f99 elementor-widget elementor-widget-text-editor\" data-id=\"8215f99\" 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\":\"This course offers a comprehensive overview of the European Medical Devices Regulation (MDR 2017\/745). It is designed to help professionals understand the structure, intent, and practical application of the regulation, supporting consistent interpretation of requirements across regulatory, quality, and product teams. \"}]\" data-inline-monday=\"true\">Ce cours offre une vue d&rsquo;ensemble du r\u00e8glement europ\u00e9en sur les dispositifs m\u00e9dicaux (MDR 2017\/745). Il est con\u00e7u pour aider les professionnels \u00e0 comprendre la structure, l&rsquo;intention et l&rsquo;application pratique du r\u00e8glement, en soutenant une interpr\u00e9tation coh\u00e9rente des exigences au sein des \u00e9quipes de r\u00e9glementation, de qualit\u00e9 et de produits. <\/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-3d3f68f e-con-full e-flex e-con e-child\" data-id=\"3d3f68f\" 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-efd8d4a elementor-widget elementor-widget-heading\" data-id=\"efd8d4a\" 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\">UK MDR 2002 - R\u00e8glement sur 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-41697f2 elementor-widget elementor-widget-text-editor\" data-id=\"41697f2\" 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\":\"This training focuses on the regulatory framework applicable to medical devices in the United Kingdom. It supports companies that operate or plan to operate in the UK market by clarifying the structure of UK MDR 2002 and its practical implications in a post-Brexit context. \"}]\" data-inline-monday=\"true\">Cette formation se concentre sur le cadre r\u00e9glementaire applicable aux dispositifs m\u00e9dicaux au Royaume-Uni. Elle soutient les entreprises qui op\u00e8rent ou pr\u00e9voient d&rsquo;op\u00e9rer sur le march\u00e9 britannique en clarifiant la structure de UK MDR 2002 et ses implications pratiques dans un contexte post-Brexit. <\/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-eceddfa e-flex e-con-boxed e-con e-parent\" data-id=\"eceddfa\" 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-80f9aa0 e-con-full e-flex e-con e-child\" data-id=\"80f9aa0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3dc6e4b elementor-widget__width-inherit elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"3dc6e4b\" 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-85a31d7 elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"85a31d7\" 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-ba72c8e elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"ba72c8e\" 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>Ce programme s&rsquo;inscrit dans le cadre plus large de nos solutions de conformit\u00e9 r\u00e9glementaire EU MDR, qui accompagnent les fabricants tout au long du cycle de vie r\u00e9glementaire europ\u00e9en.<\/p><p>Sobel fournit un soutien r\u00e9glementaire suppl\u00e9mentaire, y compris :<\/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-99586b2 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"99586b2\" 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-85ef793 e-con-full e-flex e-con e-child\" data-id=\"85ef793\" 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-66f62f0 elementor-widget elementor-widget-heading\" data-id=\"66f62f0\" 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-europe\/medical-device-clinical-evaluation\/\" target=\"_blank\">\u00c9valuation clinique (CEP, CER)<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f751d1f elementor-widget elementor-widget-text-editor\" data-id=\"f751d1f\" 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>\u00c9valuation clinique structur\u00e9e. CEP, CER, recherche documentaire et soutien aux organismes notifi\u00e9s. <\/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-f04252c elementor-align-center elementor-widget elementor-widget-button\" data-id=\"f04252c\" 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-europe\/medical-device-clinical-evaluation\/\" 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-5fce24b e-con-full e-flex e-con e-child\" data-id=\"5fce24b\" 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-89e255c elementor-widget elementor-widget-heading\" data-id=\"89e255c\" 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-europe\/quality-management-for-medical-devices\/\" target=\"_blank\">Services de gestion de la qualit\u00e9<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-26a01ff elementor-widget elementor-widget-text-editor\" data-id=\"26a01ff\" 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\":\"Gap analysis, technical documentation, and ongoing regulatory \"},{\"attributes\":{\"sanitizedSize\":\"16px\"},\"insert\":\"for CE Mark for Medical Devices\"},{\"insert\":\".\"}]\" data-inline-monday=\"true\">Soutien \u00e0 la gestion de la qualit\u00e9, conform\u00e9ment aux exigences du r\u00e8glement MDR de l&rsquo;UE et de la norme ISO 13485.<\/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-3cecc34 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"3cecc34\" 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-europe\/quality-management-for-medical-devices\/\" 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-c5bca7a e-con-full e-flex e-con e-child\" data-id=\"c5bca7a\" 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-4e0f618 elementor-widget elementor-widget-heading\" data-id=\"4e0f618\" 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-europe\/ce-mark-medical-devices-support\/\" target=\"_blank\">Soutien r\u00e9glementaire pour le marquage CE<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-faca745 elementor-widget elementor-widget-text-editor\" data-id=\"faca745\" 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\":\"TRA aligned with EU MDR and ISO 10993 series, supporting chemical safety evidence.\"}]\" data-inline-monday=\"true\">Analyse des lacunes, documentation technique et r\u00e9glementation permanente pour le marquage CE des 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 class=\"elementor-element elementor-element-78bb199 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"78bb199\" 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-europe\/ce-mark-medical-devices-support\/\" 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-fb162e2 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"fb162e2\" 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-14e99cf e-con-full e-flex e-con e-child\" data-id=\"14e99cf\" 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-ed0da40 e-con-full e-flex e-con e-child\" data-id=\"ed0da40\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2090fbb elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"2090fbb\" 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\">Transformez les exigences r\u00e9glementaires en connaissances pratiques pour votre \u00e9quipe<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a96b24c elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"a96b24c\" 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\":\"Strong regulatory knowledge is a strategic asset. Sobel\u2019s European regulatory affairs training programs help organizations build confident teams, improve compliance practices, and navigate European and UK regulatory requirements with clarity. Connect with our team to build a practical pathway to regulatory expertise in Europe.\"}]\" data-inline-monday=\"true\">Une solide connaissance de la r\u00e9glementation est un atout strat\u00e9gique. Les programmes de formation aux affaires r\u00e9glementaires europ\u00e9ennes de Sobel aident les organisations \u00e0 constituer des \u00e9quipes confiantes, \u00e0 am\u00e9liorer les pratiques de conformit\u00e9 et \u00e0 naviguer avec clart\u00e9 dans les exigences r\u00e9glementaires europ\u00e9ennes et britanniques. Contactez notre \u00e9quipe pour construire un parcours pratique vers l&rsquo;expertise r\u00e9glementaire en Europe.  <\/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-9d75f62 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"9d75f62\" 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\">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<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-61e00ee e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"61e00ee\" 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-fef4cb7 elementor-widget__width-inherit elementor-widget elementor-widget-toggle\" data-id=\"fef4cb7\" 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-2671\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-2671\" 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-2671\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-2671\"><p><b>1. Qui doit participer \u00e0 la formation sur les affaires r\u00e9glementaires europ\u00e9ennes ?<\/b><\/p>\n<p>Ces formations s&rsquo;adressent aux professionnels de l&rsquo;\u00e9valuation des risques et de l&rsquo;assurance qualit\u00e9, aux chefs de produits, aux sp\u00e9cialistes de la r\u00e9glementation et aux \u00e9quipes dirigeantes impliqu\u00e9es dans la prise de d\u00e9cision r\u00e9glementaire, les soumissions, les activit\u00e9s post-commercialisation ou la surveillance de la conformit\u00e9 des dispositifs m\u00e9dicaux.<\/p>\n<p><b>2. La formation aux affaires r\u00e9glementaires europ\u00e9ennes est-elle adapt\u00e9e aux d\u00e9butants ?<\/b><\/p>\n<p>Oui. Certains cours sont con\u00e7us comme des formations de base, introduisant les concepts et processus r\u00e9glementaires cl\u00e9s. D&rsquo;autres sont plus avanc\u00e9s et s&rsquo;adressent \u00e0 des professionnels ayant d\u00e9j\u00e0 une exp\u00e9rience en mati\u00e8re de r\u00e9glementation. Les organisations peuvent choisir une ou plusieurs formations en fonction du niveau de maturit\u00e9 de leur \u00e9quipe.   <\/p>\n<p><b>3. Comment la formation europ\u00e9enne aux affaires r\u00e9glementaires est-elle dispens\u00e9e ?<\/b><\/p>\n<p>Les formations peuvent \u00eatre dispens\u00e9es en ligne ou sur place, en fonction du cours et des besoins de l&rsquo;entreprise. Les sessions sont anim\u00e9es par des professionnels exp\u00e9riment\u00e9s et mettent l&rsquo;accent sur l&rsquo;interpr\u00e9tation pratique des exigences r\u00e9glementaires plut\u00f4t que sur le seul contenu th\u00e9orique. <\/p>\n<p><b>4. La formation aux affaires r\u00e9glementaires europ\u00e9ennes remplace-t-elle la consultance en mati\u00e8re de r\u00e9glementation ?<\/b><\/p>\n<p>Non. La formation aux affaires r\u00e9glementaires europ\u00e9ennes ne remplace pas les services de conseil. La formation est ax\u00e9e sur le d\u00e9veloppement des connaissances et des capacit\u00e9s internes, tandis que la consultance porte sur des projets r\u00e9glementaires sp\u00e9cifiques, des soumissions ou de la documentation technique.  <\/p>\n<p><b>5. Les participants re\u00e7oivent-ils un certificat apr\u00e8s la formation ?<\/b><\/p>\n<p>Oui. Chaque participant re\u00e7oit un certificat d&rsquo;ach\u00e8vement \u00e0 l&rsquo;issue du programme de formation. <\/p>\n<p><b>6. Les entreprises peuvent-elles combiner plusieurs programmes de formation ?<\/b><\/p>\n<p>Oui. Les entreprises peuvent s&rsquo;appuyer sur un ou plusieurs programmes de formation aux affaires r\u00e9glementaires europ\u00e9ennes, en fonction de leur champ d&rsquo;application r\u00e9glementaire, de leur portefeuille de dispositifs et de leurs objectifs de formation interne. <\/p>\n<p><b>7. Comment choisir la bonne formation en affaires r\u00e9glementaires europ\u00e9ennes pour notre \u00e9quipe ?<\/b><\/p>\n<p>La formation la plus appropri\u00e9e d\u00e9pend de vos responsabilit\u00e9s r\u00e9glementaires, de votre niveau d&rsquo;exp\u00e9rience et de vos march\u00e9s cibles. Sobel peut vous aider \u00e0 identifier les programmes de formation qui correspondent le mieux aux besoins de votre organisation. <\/p>\n<p><strong>8. Quelles sont les r\u00e9glementations couvertes par les programmes europ\u00e9ens de formation aux affaires r\u00e9glementaires ?<\/strong><\/p>\n<p>Les programmes de formation couvrent g\u00e9n\u00e9ralement les principaux cadres r\u00e9glementaires europ\u00e9ens tels que l&rsquo;EU MDR 2017\/745, les exigences du MDR britannique, les proc\u00e9dures de marquage CE, les normes de gestion des risques telles que l&rsquo;ISO 14971 et les obligations de surveillance apr\u00e8s la mise sur le march\u00e9, en fonction du cours s\u00e9lectionn\u00e9.<\/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>Formation aux affaires r\u00e9glementaires europ\u00e9ennes pour les dispositifs m\u00e9dicaux. Cours dispens\u00e9s par des experts sur le MDR de l&rsquo;UE, le marquage CE, le MDR du Royaume-Uni et la conformit\u00e9 du cycle de vie.<\/p>\n","protected":false},"author":11,"featured_media":7244,"parent":7809,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-8823","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>Formation aux affaires r\u00e9glementaires europ\u00e9ennes - Conformit\u00e9 au r\u00e8glement MDR de l&#039;UE<\/title>\n<meta name=\"description\" content=\"Formation aux affaires r\u00e9glementaires europ\u00e9ennes pour les dispositifs m\u00e9dicaux. 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