{"id":25749,"date":"2026-01-08T17:25:10","date_gmt":"2026-01-08T20:25:10","guid":{"rendered":"https:\/\/sobelconsult.com\/our-solutions-europe\/medical-device-internal-audits\/"},"modified":"2026-02-03T10:21:04","modified_gmt":"2026-02-03T13:21:04","slug":"medical-device-internal-audits","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/fr\/our-solutions-europe\/medical-device-internal-audits\/","title":{"rendered":"MED UE Audit interne"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"25749\" class=\"elementor elementor-25749 elementor-25724\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0ea6921 e-flex e-con-boxed e-con e-parent\" data-id=\"0ea6921\" 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-73efaff elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"73efaff\" 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\">Audits internes des dispositifs m\u00e9dicaux<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-678c323 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"678c323\" 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\":\"Medical device internal audits are essential to verify whether your quality management system works in practice and meets European regulatory expectations. Through structured audits aligned with ISO 13485, Sobel supports manufacturers in identifying risks early and preparing with confidence for notified body and regulatory inspections.\"}]\" data-inline-monday=\"true\">Les audits internes des dispositifs m\u00e9dicaux sont essentiels pour v\u00e9rifier si votre syst\u00e8me de gestion de la qualit\u00e9 fonctionne dans la pratique et r\u00e9pond aux attentes r\u00e9glementaires europ\u00e9ennes. Gr\u00e2ce \u00e0 des audits structur\u00e9s conformes \u00e0 la norme ISO 13485, Sobel aide les fabricants \u00e0 identifier les risques \u00e0 un stade pr\u00e9coce et \u00e0 se pr\u00e9parer en toute confiance aux inspections des organismes notifi\u00e9s et des autorit\u00e9s r\u00e9glementaires. <\/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-b92ba15 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"b92ba15\" 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-5f65b73 e-flex e-con-boxed e-con e-parent\" data-id=\"5f65b73\" 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-46dbc4c e-con-full e-flex e-con e-child\" data-id=\"46dbc4c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-ba87dd4 e-con-full e-transform e-flex e-con e-child\" data-id=\"ba87dd4\" 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-e91cf42 elementor-widget elementor-widget-heading\" data-id=\"e91cf42\" 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-d719490 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"d719490\" 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-2906542 elementor-align-end elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"2906542\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Fabricants de dispositifs m\u00e9dicaux qui commercialisent ou pr\u00e9voient de commercialiser des produits sur le march\u00e9 europ\u00e9en<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Entreprises mettant en \u0153uvre, maintenant ou am\u00e9liorant un syst\u00e8me de gestion de la qualit\u00e9 ISO 13485<\/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 charg\u00e9es de la r\u00e9glementation et de la qualit\u00e9 qui se pr\u00e9parent \u00e0 la certification, \u00e0 la surveillance ou aux audits d'organismes notifi\u00e9s<\/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 \u00e0 la recherche d'un audit interne ind\u00e9pendant et objectif conforme aux attentes europ\u00e9ennes<\/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-27abdfb e-con-full e-flex e-con e-child\" data-id=\"27abdfb\" 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-097dcc0 elementor-widget elementor-widget-image\" data-id=\"097dcc0\" 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-b8d6305 e-flex e-con-boxed e-con e-parent\" data-id=\"b8d6305\" 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-8854b55 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"8854b55\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"A structured audit helps organizations understand whether their quality system works in practice \u2014 not only on paper.\"}]\" data-inline-monday=\"true\">Un audit structur\u00e9 aide les organisations \u00e0 comprendre si leur syst\u00e8me de qualit\u00e9 fonctionne dans la pratique - et pas seulement sur le papier.<\/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-35caf20 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"35caf20\" 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-cff9506 e-flex e-con-boxed e-con e-parent\" data-id=\"cff9506\" 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-029d800 elementor-widget-mobile__width-inherit elementor-widget elementor-widget-image\" data-id=\"029d800\" 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-a1947ed elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"a1947ed\" 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-a5b38a0 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"a5b38a0\" 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-ac05d15 e-con-full e-flex e-con e-child\" data-id=\"ac05d15\" 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-0baecc0 elementor-widget elementor-widget-text-editor\" data-id=\"0baecc0\" 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\":\"Medical device manufacturers in Europe are expected to demonstrate that their quality management system is documented, effectively implemented, and controlled in practice.\"}]\" data-inline-monday=\"true\">Les fabricants de dispositifs m\u00e9dicaux en Europe doivent d\u00e9montrer que leur syst\u00e8me de gestion de la qualit\u00e9 est document\u00e9, mis en \u0153uvre de mani\u00e8re efficace et contr\u00f4l\u00e9 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-4af303d e-con-full e-flex e-con e-child\" data-id=\"4af303d\" 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-ec99495 elementor-widget elementor-widget-text-editor\" data-id=\"ec99495\" 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\":\"Internal audits are a key mechanism for identifying risks and non-conformities early, helping to reduce findings during notified body audits and regulatory inspections.\"}]\" data-inline-monday=\"true\">Les audits internes constituent un m\u00e9canisme essentiel pour identifier les risques et les non-conformit\u00e9s \u00e0 un stade pr\u00e9coce, ce qui permet de r\u00e9duire les conclusions des audits des organismes notifi\u00e9s et des inspections r\u00e9glementaires.<\/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-a656380 e-con-full e-flex e-con e-child\" data-id=\"a656380\" 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-a2ea91d elementor-widget elementor-widget-text-editor\" data-id=\"a2ea91d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"A structured internal audit also supports continuous improvement, strengthens regulatory readiness, and provides objective evidence of alignment with ISO 13485 and European regulatory expectations.\"}]\" data-inline-monday=\"true\">Un audit interne structur\u00e9 favorise \u00e9galement l&rsquo;am\u00e9lioration continue, renforce la pr\u00e9paration \u00e0 la r\u00e9glementation et fournit des preuves objectives de l&rsquo;alignement sur la norme ISO 13485 et les attentes de la r\u00e9glementation europ\u00e9enne.<\/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-f47756c e-flex e-con-boxed e-con e-parent\" data-id=\"f47756c\" 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-2b7ea1d e-con-full e-flex e-con e-child\" data-id=\"2b7ea1d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-97e0709 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"97e0709\" 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\">Audits internes align\u00e9s sur les attentes r\u00e9glementaires europ\u00e9ennes<\/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-30cd411 e-con-full e-flex e-con e-child\" data-id=\"30cd411\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dd3068f elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"dd3068f\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Sobel delivers a transparent and structured approach, conducted remotely or on-site according to your organization\u2019s needs, with a strong focus on objective evidence, traceability, and clear documentation of findings.\"}]\" data-inline-monday=\"true\">Sobel propose une approche transparente et structur\u00e9e, men\u00e9e \u00e0 distance ou sur place selon les besoins de votre organisation, en mettant l&rsquo;accent sur les preuves objectives, la tra\u00e7abilit\u00e9 et la documentation claire des r\u00e9sultats.<\/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-5ee6c16 e-flex e-con-boxed e-con e-parent\" data-id=\"5ee6c16\" 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-76df003 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"76df003\" 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\">Permettez \u00e0 votre \u00e9quipe de transformer les r\u00e9sultats des audits en am\u00e9liorations structur\u00e9es et en renforcement du contr\u00f4le 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-cca749c elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"cca749c\" 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_cca749c *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_cca749c{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_cca749c .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_cca749c .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_cca749c .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_cca749c .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_cca749c .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_cca749c .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_cca749c .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_cca749c .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_cca749c  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_cca749c  .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_cca749c .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_cca749c .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_cca749c .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_cca749c .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_cca749c .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_cca749c .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_cca749c .ue-item-bullet i, #uc_horizontal_timeline_elementor_cca749c .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_cca749c .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_cca749c .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_cca749c .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_cca749c .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_cca749c .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_cca749c .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_cca749c .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_cca749c .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_cca749c .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_cca749c\">\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_cca749c\" data-custom-sethtml=\"true\"  >\n     \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-2a39b39\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Planification de l'audit<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">D\u00e9finition de la port\u00e9e de l'audit, de la norme applicable, du format de l'audit (\u00e0 distance ou sur place), du calendrier et de la documentation \u00e0 examiner.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-446e8d1\">\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=\"#\" >Examen de la documentation<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">V\u00e9rification de l'exhaustivit\u00e9 des proc\u00e9dures document\u00e9es et de leur conformit\u00e9 \u00e0 la norme applicable.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-bab004b\">\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=\"#\" >Processus d'audit<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">V\u00e9rification de la mise en \u0153uvre effective des proc\u00e9dures au sein de l'organisation, sur la base de preuves objectives.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-6996f21\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Rapports d'audit<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">R\u00e9daction d'un rapport d'audit r\u00e9sumant les r\u00e9sultats de l'audit, les observations et les non-conformit\u00e9s identifi\u00e9es.<\/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-1bde354 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"1bde354\" 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-c48ef1f e-flex e-con-boxed e-con e-parent\" data-id=\"c48ef1f\" 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-7335242 e-con-full e-flex e-con e-child\" data-id=\"7335242\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2b90e53 elementor-widget__width-inherit elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"2b90e53\" 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-f8d2e74 elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"f8d2e74\" 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-30bdefc elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"30bdefc\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"A robust internal audit process supports risk-based decision-making and demonstrates a proactive compliance culture. As part of a broader quality and regulatory strategy, Sobel offers additional services that complement internal audits, including:\"}]\" data-inline-monday=\"true\">Un processus d&rsquo;audit interne solide soutient la prise de d\u00e9cision bas\u00e9e sur le risque et d\u00e9montre une culture de conformit\u00e9 proactive. Dans le cadre d&rsquo;une strat\u00e9gie plus large en mati\u00e8re de qualit\u00e9 et de r\u00e9glementation, Sobel propose des services suppl\u00e9mentaires qui compl\u00e8tent les audits internes : <\/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-eed8304 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"eed8304\" 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-8c630ea e-con-full e-flex e-con e-child\" data-id=\"8c630ea\" 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-d796296 elementor-widget elementor-widget-heading\" data-id=\"d796296\" 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\">Audit et qualification des fournisseurs<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-861617b elementor-widget elementor-widget-text-editor\" data-id=\"861617b\" 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\":\"We audit medical suppliers to ensure quality and GMP compliance.\"}]\" data-inline-monday=\"true\">Nous contr\u00f4lons les fournisseurs de produits m\u00e9dicaux afin de garantir la qualit\u00e9 et la conformit\u00e9 aux BPF.<\/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-93c3e38 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"93c3e38\" 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\/supplier-qualification-audit\/\" 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-7bc2d6d e-con-full e-flex e-con e-child\" data-id=\"7bc2d6d\" 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-357057b elementor-widget elementor-widget-heading\" data-id=\"357057b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Soutien r\u00e9glementaire pour le marquage CE<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1caedea elementor-widget elementor-widget-text-editor\" data-id=\"1caedea\" 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\">Analyse des lacunes, documentation technique et r\u00e9glementation permanente pour le marquage CE des dispositifs m\u00e9dicaux.<\/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-da40d5e elementor-align-center elementor-widget elementor-widget-button\" data-id=\"da40d5e\" 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<div class=\"elementor-element elementor-element-46a10a2 e-con-full e-flex e-con e-child\" data-id=\"46a10a2\" 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-cba323c elementor-widget elementor-widget-heading\" data-id=\"cba323c\" 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\">Repr\u00e9sentant europ\u00e9en autoris\u00e9<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c18f7a9 elementor-widget elementor-widget-text-editor\" data-id=\"c18f7a9\" 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\":\"EAR for medical devices, supporting regulatory oversight and access to the EU market.\"}]\" data-inline-monday=\"true\">EAR pour les dispositifs m\u00e9dicaux, soutenant la surveillance r\u00e9glementaire et l&rsquo;acc\u00e8s au march\u00e9 de l&rsquo;UE.<\/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-0f88a60 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"0f88a60\" 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\/european-authorized-representative-europe\/\" 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-876544b e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"876544b\" 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-1bdfca3 e-con-full e-flex e-con e-child\" data-id=\"1bdfca3\" 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-e2491af e-con-full e-flex e-con e-child\" data-id=\"e2491af\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-cbdd186 elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"cbdd186\" 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\">Des audits internes qui permettent de prendre des d\u00e9cisions r\u00e9glementaires en toute confiance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-97e7837 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"97e7837\" 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\":\"Medical device internal audits provide clarity, structure, and confidence in your quality management system. Sobel supports organizations with independent audits that deliver actionable insights and clear documentation, helping teams stay prepared for notified body interactions and European regulatory expectations.\"}]\" data-inline-monday=\"true\">Les audits internes des dispositifs m\u00e9dicaux apportent clart\u00e9, structure et confiance dans votre syst\u00e8me de gestion de la qualit\u00e9. Sobel soutient les organisations avec des audits ind\u00e9pendants qui fournissent des informations exploitables et une documentation claire, aidant les \u00e9quipes \u00e0 se pr\u00e9parer aux interactions avec les organismes notifi\u00e9s et aux attentes r\u00e9glementaires europ\u00e9ennes. <\/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-40ed6c3 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"40ed6c3\" 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-3dd1d84 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"3dd1d84\" 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-1392b09 elementor-widget__width-inherit elementor-widget elementor-widget-toggle\" data-id=\"1392b09\" 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-2051\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-2051\" 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-2051\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-2051\"><p><b>1. Quel est l&rsquo;objectif d&rsquo;un audit interne pour les fabricants de dispositifs m\u00e9dicaux en Europe ?<\/b><\/p>\n<p>Les audits internes permettent de v\u00e9rifier si le syst\u00e8me de gestion de la qualit\u00e9 est effectivement mis en \u0153uvre et align\u00e9 sur les normes applicables, telles que la norme ISO 13485. Dans le contexte europ\u00e9en, ils permettent \u00e9galement de se pr\u00e9parer aux audits des organismes notifi\u00e9s et aux inspections r\u00e9glementaires en identifiant rapidement les lacunes et les risques. <\/p>\n<p><b>2. Les audits internes sont-ils obligatoires en vertu de la r\u00e9glementation europ\u00e9enne ?<\/b><\/p>\n<p>Oui. La norme ISO 13485 exige des fabricants qu&rsquo;ils proc\u00e8dent \u00e0 des audits internes \u00e0 des intervalles planifi\u00e9s. Bien que le RIM de l&rsquo;UE ne prescrive pas la mani\u00e8re dont les audits doivent \u00eatre r\u00e9alis\u00e9s, les organismes notifi\u00e9s attendent des preuves d&rsquo;un processus d&rsquo;audit interne solide et efficace dans le cadre de l&rsquo;\u00e9valuation des syst\u00e8mes de qualit\u00e9.  <\/p>\n<p><b>3. Quelle est la diff\u00e9rence entre un audit interne et un audit d&rsquo;un organisme notifi\u00e9 ?<\/b><\/p>\n<p>Un audit interne est r\u00e9alis\u00e9 par l&rsquo;organisation ou en son nom afin d&rsquo;\u00e9valuer ses propres processus et sa conformit\u00e9. Un audit d&rsquo;un organisme notifi\u00e9 est une \u00e9valuation externe de la conformit\u00e9 r\u00e9alis\u00e9e par un organisme d\u00e9sign\u00e9 \u00e0 des fins de certification ou de surveillance. Les audits internes aident les organisations \u00e0 se pr\u00e9parer aux audits des organismes notifi\u00e9s et \u00e0 r\u00e9duire le risque de constatations.  <\/p>\n<p><b>4. Les audits internes peuvent-ils \u00eatre r\u00e9alis\u00e9s \u00e0 distance en Europe ?<\/b><\/p>\n<p>Oui. Les audits internes \u00e0 distance sont largement accept\u00e9s en Europe lorsqu&rsquo;ils sont planifi\u00e9s et ex\u00e9cut\u00e9s de mani\u00e8re appropri\u00e9e. Le format de l&rsquo;audit (\u00e0 distance ou sur place) doit \u00eatre d\u00e9fini en fonction du champ d&rsquo;application, du risque et des besoins de l&rsquo;organisation, tout en garantissant l&rsquo;acc\u00e8s \u00e0 des preuves objectives et une interaction efficace avec le personnel concern\u00e9.  <\/p>\n<p><b>5. Quelles sont les normes qui peuvent \u00eatre couvertes lors d&rsquo;un audit interne ?<\/b><\/p>\n<p>Les audits internes sont g\u00e9n\u00e9ralement align\u00e9s sur la norme ISO 13485, mais le champ d&rsquo;application peut \u00e9galement inclure les proc\u00e9dures du syst\u00e8me de qualit\u00e9, les exigences du RIM de l&rsquo;UE et les politiques internes, en fonction de la strat\u00e9gie r\u00e9glementaire et des objectifs d&rsquo;audit de l&rsquo;organisation.<\/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>Audits internes des dispositifs m\u00e9dicaux pour soutenir la conformit\u00e9 \u00e0 la norme ISO 13485, l&rsquo;identification des risques et la pr\u00e9paration aux audits des organismes notifi\u00e9s en Europe.<\/p>\n","protected":false},"author":15,"featured_media":25638,"parent":7809,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-25749","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>Audits internes des dispositifs m\u00e9dicaux en Europe<\/title>\n<meta name=\"description\" content=\"Audits internes des dispositifs m\u00e9dicaux pour soutenir la conformit\u00e9 \u00e0 la norme ISO 13485, l&#039;identification des risques et la pr\u00e9paration aux audits des organismes notifi\u00e9s en Europe.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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