{"id":22175,"date":"2025-11-27T21:43:00","date_gmt":"2025-11-28T00:43:00","guid":{"rendered":"https:\/\/sobelconsult.com\/materiais\/eu-iso14971-risk\/"},"modified":"2026-02-09T17:10:38","modified_gmt":"2026-02-09T20:10:38","slug":"eu-iso14971-risk","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/fr\/materiais\/eu-iso14971-risk\/","title":{"rendered":"Dossier de gestion des risques (ISO 14971 \/ MDR) | Co-d\u00e9velopp\u00e9 avec votre \u00e9quipe"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"22175\" class=\"elementor elementor-22175 elementor-22168\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a2ec226 e-flex e-con-boxed e-con e-parent\" data-id=\"a2ec226\" 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-c666b4a e-con-full e-flex e-con e-child\" data-id=\"c666b4a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-16b154e elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"16b154e\" 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=\"741\" height=\"290\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-BlueSea.png\" class=\"attachment-full size-full wp-image-4675\" alt=\"Logo Sobel\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-BlueSea.png 741w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-BlueSea-300x117.png 300w\" sizes=\"(max-width: 741px) 100vw, 741px\" \/>\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-f0c7184 elementor-align-left elementor-widget elementor-widget-button\" data-id=\"f0c7184\" 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 elementor-animation-pulse\" href=\"#cta\">\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<i aria-hidden=\"true\" class=\" ti-location-arrow\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Parler \u00e0 Sobel<\/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-c1e8144 e-con-full e-flex e-con e-child\" data-id=\"c1e8144\" 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-ff18479 elementor-widget elementor-widget-heading\" data-id=\"ff18479\" 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<h4 class=\"elementor-heading-title elementor-size-default\">Union europ\u00e9enne - Gestion des risques (ISO 14971 \/ MDR)<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f759199 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"f759199\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Dossier de gestion des risques - ISO 14971 \/ MDR align\u00e9<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c90e7b8 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"c90e7b8\" 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\">En vertu du r\u00e8glement europ\u00e9en sur les m\u00e9dicaments, les fabricants doivent \u00e9tablir, documenter, mettre en \u0153uvre et tenir \u00e0 jour un syst\u00e8me de gestion des risques. Le dossier de gestion des risques (FGR) est au centre de ce syst\u00e8me : il doit relier les dangers, les contr\u00f4les des risques, le risque r\u00e9siduel, les GSPR et la surveillance apr\u00e8s la mise sur le march\u00e9 d'une mani\u00e8re que les auditeurs et les organismes notifi\u00e9s peuvent suivre. <\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4fc484e elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"4fc484e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" Sobel leads and structures an ISO 14971 \/ MDR-aligned Risk Management File together with your team: we run discovery, expand hazards, build risk tables, write draft residual-risk narratives, create the GSPR mapping, and set a PMS-linked maintenance plan\u2014using your device knowledge, policies, and judgments. Final content decisions and approval remain with the Legal Manufacturer.\"}]\" data-inline-monday=\"true\"><strong>Sobel dirige et structure un dossier de gestion des risques conforme \u00e0 la norme ISO 14971 \/ MDR en collaboration avec votre \u00e9quipe : nous proc\u00e9dons \u00e0 la d\u00e9couverte, \u00e9largissons les dangers, construisons des tableaux de risques, r\u00e9digeons des projets de narration des risques r\u00e9siduels, cr\u00e9ons la cartographie GSPR et \u00e9tablissons un plan de maintenance li\u00e9 au PMS - en utilisant vos connaissances, vos politiques et vos jugements en mati\u00e8re d&rsquo;appareils. Les d\u00e9cisions finales concernant le contenu et l&rsquo;approbation restent du ressort du fabricant l\u00e9gal. <\/strong><\/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-1c47713 e-con-full e-flex e-con e-child\" data-id=\"1c47713\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-344982c e-con-full e-flex e-con e-child\" data-id=\"344982c\" 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-1ffa386 elementor-widget elementor-widget-text-editor\" data-id=\"1ffa386\" 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><strong>ISO 14971 &amp; MDR-aligned RMF (co-d\u00e9velopp\u00e9)<\/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<div class=\"elementor-element elementor-element-78c976a e-con-full e-flex e-con e-child\" data-id=\"78c976a\" 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-5bd9c67 elementor-widget elementor-widget-text-editor\" data-id=\"5bd9c67\" 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><strong>Extension de la couverture des dangers et des tableaux de risques<\/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<div class=\"elementor-element elementor-element-a37e6b0 e-con-full e-flex e-con e-child\" data-id=\"a37e6b0\" 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-3545ed9 elementor-widget elementor-widget-text-editor\" data-id=\"3545ed9\" 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><strong>Projets d&rsquo;expos\u00e9s sur les risques r\u00e9siduels et les risques-avantages<\/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<div class=\"elementor-element elementor-element-93cae40 e-con-full e-flex e-con e-child\" data-id=\"93cae40\" 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-7c6b2fb elementor-widget elementor-widget-text-editor\" data-id=\"7c6b2fb\" 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><strong>Cartographie du RGPD (annexe I)<\/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<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-72bdd93 elementor-align-left borda-piscando elementor-widget elementor-widget-button\" data-id=\"72bdd93\" 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 elementor-animation-pulse\" href=\"#cta\">\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-far-envelope\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 64H48C21.49 64 0 85.49 0 112v288c0 26.51 21.49 48 48 48h416c26.51 0 48-21.49 48-48V112c0-26.51-21.49-48-48-48zm0 48v40.805c-22.422 18.259-58.168 46.651-134.587 106.49-16.841 13.247-50.201 45.072-73.413 44.701-23.208.375-56.579-31.459-73.413-44.701C106.18 199.465 70.425 171.067 48 152.805V112h416zM48 400V214.398c22.914 18.251 55.409 43.862 104.938 82.646 21.857 17.205 60.134 55.186 103.062 54.955 42.717.231 80.509-37.199 103.053-54.947 49.528-38.783 82.032-64.401 104.947-82.653V400H48z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Construire mon dossier de gestion des risques<\/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 class=\"elementor-element elementor-element-632024d elementor-widget elementor-widget-spacer\" data-id=\"632024d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e1d98e8 e-con-full e-transform e-flex e-con e-parent\" data-id=\"e1d98e8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;_transform_translateX_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:-48,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-efdbbf8 elementor-widget elementor-widget-image-carousel\" data-id=\"efdbbf8\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;slides_to_show&quot;:&quot;7&quot;,&quot;slides_to_scroll&quot;:&quot;1&quot;,&quot;navigation&quot;:&quot;none&quot;,&quot;autoplay_speed&quot;:3000,&quot;speed&quot;:1500,&quot;image_spacing_custom&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:4,&quot;sizes&quot;:[]},&quot;slides_to_show_mobile&quot;:&quot;2&quot;,&quot;autoplay&quot;:&quot;yes&quot;,&quot;pause_on_hover&quot;:&quot;yes&quot;,&quot;pause_on_interaction&quot;:&quot;yes&quot;,&quot;infinite&quot;:&quot;yes&quot;,&quot;image_spacing_custom_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;image_spacing_custom_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;image_spacing_custom_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"image-carousel.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-image-carousel-wrapper swiper\" role=\"region\" aria-roledescription=\"carousel\" aria-label=\"Image Carousel\" dir=\"ltr\">\n\t\t\t<div class=\"elementor-image-carousel swiper-wrapper\" aria-live=\"off\">\n\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"1 sur 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client2-Sobel-r055w2cgedt2i71p0r1xeqnh0whcf5ht807j9pns4g.jpg\" alt=\"CMOS DRAKE logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"2 sur 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" 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src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client8-Sobel-r055w63t5py7smw8esofoppbefyt9xwqkith6ti7fk.jpg\" alt=\"Braun logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"8 sur 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client9-Sobel-r055w71ncjzi48uv9b3297grztu6hn0gwngyo3gt9c.jpg\" alt=\"Hypera Pharma logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"9 sur 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client10-Sobel-r055w7zhje0sfuti3thotp88l7pjpc478s4g5dff34.jpg\" alt=\"M Vision logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"10 sur 10\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/Logo-Client1-Sobel-r055w2cgedt2i71p0r1xeqnh0whcf5ht807j9pns4g.jpg\" alt=\"Andratec logo\" \/><\/figure><\/div>\t\t\t<\/div>\n\t\t\t\t\t\t\t\n\t\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<\/div>\n\t\t<div class=\"elementor-element elementor-element-46366cb elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile e-flex e-con-boxed e-con e-parent\" data-id=\"46366cb\" 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-d4b9acc e-con-full e-flex e-con e-child\" data-id=\"d4b9acc\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-964bba0 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"964bba0\" 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\">L'importance de l'enregistrement des \u00e9tablissements et de la liste des appareils<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ef53295 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"ef53295\" 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\":\" If you manufacture, develop, relabel, or import medical devices in the U.S., registration and listing are not optional\u2014they are required under 21 CFR Part 807 and must be kept current.\"}]\" data-inline-monday=\"true\"><strong>Si vous fabriquez, d\u00e9veloppez, r\u00e9\u00e9tiqueter ou importez des dispositifs m\u00e9dicaux aux \u00c9tats-Unis, l&rsquo;enregistrement et l&rsquo;inscription ne sont pas facultatifs : ils sont exig\u00e9s par le r\u00e8glement 21 CFR Part 807 et doivent \u00eatre tenus \u00e0 jour.<\/strong><\/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-541d9e5 elementor-align-left borda-piscando elementor-widget elementor-widget-button\" data-id=\"541d9e5\" 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 elementor-animation-pulse\" href=\"#cta\">\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-far-envelope\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 64H48C21.49 64 0 85.49 0 112v288c0 26.51 21.49 48 48 48h416c26.51 0 48-21.49 48-48V112c0-26.51-21.49-48-48-48zm0 48v40.805c-22.422 18.259-58.168 46.651-134.587 106.49-16.841 13.247-50.201 45.072-73.413 44.701-23.208.375-56.579-31.459-73.413-44.701C106.18 199.465 70.425 171.067 48 152.805V112h416zM48 400V214.398c22.914 18.251 55.409 43.862 104.938 82.646 21.857 17.205 60.134 55.186 103.062 54.955 42.717.231 80.509-37.199 103.053-54.947 49.528-38.783 82.032-64.401 104.947-82.653V400H48z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Parler \u00e0 Sobel<\/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-da741ac e-con-full e-flex e-con e-child\" data-id=\"da741ac\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4820678 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"4820678\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>Obligations obligatoires :<\/strong> Les \u00e9tablissements am\u00e9ricains de dispositifs doivent s'enregistrer aupr\u00e8s de la FDA et r\u00e9pertorier leurs dispositifs ; cela s'applique aux fabricants, aux d\u00e9veloppeurs de sp\u00e9cifications, aux fabricants sous contrat, aux reconditionneurs\/r\u00e9\u00e9tiquet\u00e9s et aux importateurs initiaux bas\u00e9s aux \u00c9tats-Unis.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>Les d\u00e9lais s'appliquent :<\/strong> L'enregistrement initial de l'\u00e9tablissement et la liste des dispositifs doivent \u00eatre effectu\u00e9s dans les 30 jours suivant le d\u00e9but des activit\u00e9s li\u00e9es aux dispositifs r\u00e9glement\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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>Frais d'utilisation annuels :<\/strong> Chaque ann\u00e9e, entre le 1er octobre et le 31 d\u00e9cembre, les \u00e9tablissements doivent revoir\/mettre \u00e0 jour leur enregistrement et leurs listes et payer la redevance d'utilisation de l'enregistrement des \u00e9tablissements de la FDA. L'enregistrement ne peut \u00eatre effectu\u00e9 tant que la FDA n'a pas re\u00e7u et trait\u00e9 cette redevance. <\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>Syst\u00e8me en ligne :<\/strong> Toutes les activit\u00e9s d'enregistrement et d'inscription sont g\u00e9r\u00e9es par FURLS et le module d'enregistrement et d'inscription des dispositifs (DRLM).<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>Il ne s'agit pas d'une approbation :<\/strong> Le fait d'\u00eatre enregistr\u00e9 ou r\u00e9pertori\u00e9 ne signifie pas que la FDA a approuv\u00e9 ou homologu\u00e9 vos dispositifs ; cela signifie seulement que votre \u00e9tablissement et vos dispositifs figurent dans les bases de donn\u00e9es de la FDA.<\/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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fe4305f e-flex e-con-boxed e-con e-parent\" data-id=\"fe4305f\" 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-52f5046 e-con-full e-flex e-con e-child\" data-id=\"52f5046\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fabcb35 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"fabcb35\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h6 class=\"elementor-heading-title elementor-size-default\">Un cadre RMF structur\u00e9, \u00e9labor\u00e9 avec vos experts, que les organismes notifi\u00e9s et les auditeurs peuvent suivre.<\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-527b71f elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"527b71f\" 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_527b71f *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_527b71f{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_527b71f .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_527b71f .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_527b71f .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_527b71f .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_527b71f .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_527b71f .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_527b71f .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_527b71f .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_527b71f  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_527b71f  .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_527b71f .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_527b71f .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_527b71f .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_527b71f .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_527b71f .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_527b71f .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_527b71f .ue-item-bullet i, #uc_horizontal_timeline_elementor_527b71f .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_527b71f .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_527b71f .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_527b71f .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_527b71f .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_527b71f .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_527b71f .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_527b71f .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_527b71f .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_527b71f .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_527b71f\">\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_527b71f\" data-custom-sethtml=\"true\"  >\n     \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-06b669b\">\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\u00e9couvrez avec vos PME<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\"><\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-92b5731\">\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=\"#\" >\u00c9largir les tableaux des dangers et des risques<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\"><\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-78a5455\">\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 ensemble les contr\u00f4les et les r\u00e9cits<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\"><\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-72f809d\">\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=\"#\" >Carte GSPRs<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\"><\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-4617888\">\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=\"#\" >Lien avec le PMS et le transfert<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\"><\/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>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-50b1560 e-flex e-con-boxed e-con e-parent\" data-id=\"50b1560\" 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-5a5b09e elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"5a5b09e\" 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\">Ce que vous recevrez<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c240c92 e-flex e-con-boxed e-con e-parent\" data-id=\"c240c92\" 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-5c5f839 e-con-full e-flex e-con e-child\" data-id=\"5c5f839\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d41c0a9 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"d41c0a9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Mise \u00e0 jour du dossier de gestion des risques (FGR)<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-710dcbf elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"710dcbf\" 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\">Un cadre de gestion des risques actualis\u00e9 et structur\u00e9 comprenant un plan de gestion des risques, l'identification et l'analyse des dangers, l'estimation et l'\u00e9valuation des risques, la structure de contr\u00f4le des risques et les projets de textes sur les risques r\u00e9siduels et les b\u00e9n\u00e9fices - \u00e9labor\u00e9s avec vos experts en la mati\u00e8re et finalis\u00e9s par le fabricant de mat\u00e9riel juridique.<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-49e75fd elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"49e75fd\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Identification des entit\u00e9s de votre structure qui doivent s'enregistrer en tant qu'\u00e9tablissements.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Clarification des dispositifs qui doivent \u00eatre r\u00e9pertori\u00e9s et sous quel \u00e9tablissement.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Calendrier et responsabilit\u00e9s pour l'enregistrement initial\/l'inscription sur la liste (obligation de 30 jours) et l'examen annuel d'octobre \u00e0 d\u00e9cembre.<\/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<div class=\"elementor-element elementor-element-9b7284c e-con-full e-flex e-con e-child\" data-id=\"9b7284c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2e43205 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"2e43205\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Matrice de cartographie du GSPR<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cd420cf elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"cd420cf\" 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\">Une matrice concise de correspondance GSPR pour l'annexe I du MDR : exigences li\u00e9es aux dangers, contr\u00f4les des risques et preuves \u00e0 l'appui, sur la base de votre documentation et de vos donn\u00e9es, afin que les examinateurs puissent retracer l'exigence \u2192 le risque \u2192 le contr\u00f4le \u2192 la preuve.<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-213a058 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"213a058\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Identification des entit\u00e9s de votre structure qui doivent s'enregistrer en tant qu'\u00e9tablissements.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Clarification des dispositifs qui doivent \u00eatre r\u00e9pertori\u00e9s et sous quel \u00e9tablissement.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Calendrier et responsabilit\u00e9s pour l'enregistrement initial\/l'inscription sur la liste (obligation de 30 jours) et l'examen annuel d'octobre \u00e0 d\u00e9cembre.<\/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<div class=\"elementor-element elementor-element-e90783f e-con-full e-flex e-con e-child\" data-id=\"e90783f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0956828 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"0956828\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Paquet d'interfaces<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9f54477 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"9f54477\" 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\">Un pack d'interfaces montrant comment le RMF se connecte \u00e0 vos autres documents cl\u00e9s : Rapport d'\u00e9valuation clinique (CER), \u00c9valuation biologique \/ \u00c9valuation du risque toxicologique (BER\/TRA), fichiers d'utilisabilit\u00e9, contenu IFU\/\u00e9tiquette, et sorties PMS - construits \u00e0 partir des mat\u00e9riaux que vous fournissez.<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b7c8543 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"b7c8543\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Identification des entit\u00e9s de votre structure qui doivent s'enregistrer en tant qu'\u00e9tablissements.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Clarification des dispositifs qui doivent \u00eatre r\u00e9pertori\u00e9s et sous quel \u00e9tablissement.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Calendrier et responsabilit\u00e9s pour l'enregistrement initial\/l'inscription sur la liste (obligation de 30 jours) et l'examen annuel d'octobre \u00e0 d\u00e9cembre.<\/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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2b43054 e-flex e-con-boxed e-con e-parent\" data-id=\"2b43054\" 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-e94561d e-con-full e-flex e-con e-child\" data-id=\"e94561d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d07ef02 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"d07ef02\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Mini-plan de maintenance<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-66aae0b elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"66aae0b\" 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\">Un mini-plan de maintenance pratique d\u00e9crivant les d\u00e9clencheurs, la cadence de r\u00e9vision et les propri\u00e9taires - liant les mises \u00e0 jour du RMF aux donn\u00e9es du PMS, aux modifications de conception et aux \u00e9v\u00e9nements du cycle de vie que vous d\u00e9finissez, afin que votre \u00e9quipe puisse maintenir le fichier \u00e0 jour.<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-77cfb58 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"77cfb58\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Identification des entit\u00e9s de votre structure qui doivent s'enregistrer en tant qu'\u00e9tablissements.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Clarification des dispositifs qui doivent \u00eatre r\u00e9pertori\u00e9s et sous quel \u00e9tablissement.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Calendrier et responsabilit\u00e9s pour l'enregistrement initial\/l'inscription sur la liste (obligation de 30 jours) et l'examen annuel d'octobre \u00e0 d\u00e9cembre.<\/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<div class=\"elementor-element elementor-element-0c919c3 e-con-full e-flex e-con e-child\" data-id=\"0c919c3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-edffdd2 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"edffdd2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Journal des modifications et note d'approbation<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eff0e41 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"eff0e41\" 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\">Un journal des changements clair pour les mises \u00e0 jour du RMF et une courte note d'approbation confirmant que les parties prenantes internes du fabricant juridique examinent et signent le RMF. Sobel pr\u00e9pare et structure le contenu ; votre \u00e9quipe est responsable des d\u00e9cisions relatives aux risques et de l'approbation finale. <\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-99b2bb3 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"99b2bb3\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Identification des entit\u00e9s de votre structure qui doivent s'enregistrer en tant qu'\u00e9tablissements.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Clarification des dispositifs qui doivent \u00eatre r\u00e9pertori\u00e9s et sous quel \u00e9tablissement.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Calendrier et responsabilit\u00e9s pour l'enregistrement initial\/l'inscription sur la liste (obligation de 30 jours) et l'examen annuel d'octobre \u00e0 d\u00e9cembre.<\/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<div class=\"elementor-element elementor-element-2ef1aeb e-con-full e-flex e-con e-child\" data-id=\"2ef1aeb\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1926795 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"1926795\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Champ d'application : Consultation et documentation uniquement. Nous n'agissons pas en tant qu'organisme notifi\u00e9, importateur ou conseiller juridique. Nous ne pouvons pas cr\u00e9er un RMF complet de mani\u00e8re isol\u00e9e - nous nous appuyons sur votre connaissance des dispositifs, vos politiques et vos preuves. Le fabricant l\u00e9gal r\u00e9vise, compl\u00e8te si n\u00e9cessaire et signe le RMF.   <\/h3>\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-5888fa5 animated-slow e-con-full elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile e-flex elementor-invisible e-con e-parent\" data-id=\"5888fa5\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f9f7f09 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"f9f7f09\" 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\">Pourquoi les \u00e9quipes choisissent-elles Sobel pour des examens ind\u00e9pendants de l'\u00e9cart par rapport \u00e0 la norme ISO 10993-1 ?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-99fa7c7 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"99fa7c7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" Sobel acts as a critical, precise external reader for your biological evaluation documentation\u2014focusing on how reviewers interpret your files, not on selling generic tools.\"}]\" data-inline-monday=\"true\">Sobel agit comme un lecteur externe critique et pr\u00e9cis pour votre documentation d&rsquo;\u00e9valuation biologique - en se concentrant sur la fa\u00e7on dont les examinateurs interpr\u00e8tent vos fichiers, et non sur la vente d&rsquo;outils g\u00e9n\u00e9riques.<\/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-65a70a0 e-flex e-con-boxed e-con e-child\" data-id=\"65a70a0\" 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-b012aa9 e-con-full e-flex e-con e-child\" data-id=\"b012aa9\" 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-e3e1526 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"e3e1526\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Un point de vue ind\u00e9pendant sur la fa\u00e7on dont vos dossiers s'alignent sur la norme ISO 10993-1:2025 relative aux effets biologiques et sur l'estimation des risques selon la norme ISO 14971.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">L'accent est mis sur un seul r\u00e9sultat : un rapport sur les lacunes concis et class\u00e9 par ordre de priorit\u00e9 - pas de mod\u00e8les, de fiches d'\u00e9valuation ou de projets pr\u00eats \u00e0 l'emploi.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">L'accent est mis sur la fa\u00e7on dont la chimie (ISO 10993-18) et l'\u00e9valuation des risques toxicologiques (TRA, ISO 10993-17:2023) soutiennent les jugements de suffisance.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Des explications claires sur les points o\u00f9 les justifications sont solides, faibles ou manquantes, r\u00e9dig\u00e9es dans un langage adapt\u00e9 aux \u00e9valuateurs.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">L'exp\u00e9rience acquise sur plusieurs march\u00e9s (UE, FDA, Br\u00e9sil et autres) refl\u00e8te la mani\u00e8re dont les autorit\u00e9s int\u00e8grent la norme ISO 10993-1 dans le processus plus large de gestion des risques.<\/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\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5a829f6 e-flex e-con-boxed e-con e-parent\" data-id=\"5a829f6\" 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-17c0afb e-con-full e-flex e-con e-child\" data-id=\"17c0afb\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-240ed0d e-con-full e-flex e-con e-child\" data-id=\"240ed0d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-eea4b7b elementor-widget elementor-widget-heading\" data-id=\"eea4b7b\" 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\">Comment nous travaillons<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c4b811d elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-text-editor\" data-id=\"c4b811d\" 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 move from a clear inventory of your activities and products to a repeatable registration and listing routine.\"}]\" data-inline-monday=\"true\">Nous passons d&rsquo;un inventaire clair de vos activit\u00e9s et de vos produits \u00e0 une routine d&rsquo;enregistrement et d&rsquo;inscription reproductible.<\/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-829fddb elementor-align-left borda-piscando elementor-widget elementor-widget-button\" data-id=\"829fddb\" 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 elementor-animation-pulse\" href=\"#cta\">\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-far-envelope\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 64H48C21.49 64 0 85.49 0 112v288c0 26.51 21.49 48 48 48h416c26.51 0 48-21.49 48-48V112c0-26.51-21.49-48-48-48zm0 48v40.805c-22.422 18.259-58.168 46.651-134.587 106.49-16.841 13.247-50.201 45.072-73.413 44.701-23.208.375-56.579-31.459-73.413-44.701C106.18 199.465 70.425 171.067 48 152.805V112h416zM48 400V214.398c22.914 18.251 55.409 43.862 104.938 82.646 21.857 17.205 60.134 55.186 103.062 54.955 42.717.231 80.509-37.199 103.053-54.947 49.528-38.783 82.032-64.401 104.947-82.653V400H48z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Construire mon dossier de gestion des risques<\/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-ef433d5 e-con-full e-flex e-con e-child\" data-id=\"ef433d5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ed2b790 elementor-widget elementor-widget-image\" data-id=\"ed2b790\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"2560\" height=\"1440\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-scaled.jpg\" class=\"attachment-full size-full wp-image-15532\" alt=\"A healthcare professional&#039;s office. A laptop displays test results.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-scaled.jpg 2560w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-300x169.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-1024x576.jpg 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-768x432.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-1536x864.jpg 1536w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img1-2048x1152.jpg 2048w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2e04405 e-con-full e-flex e-con e-child\" data-id=\"2e04405\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-18ed4bb e-con-full e-flex e-con e-child\" data-id=\"18ed4bb\" 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-458488e elementor-widget elementor-widget-heading\" data-id=\"458488e\" 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\">01<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-34accad elementor-widget elementor-widget-heading\" data-id=\"34accad\" 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<h4 class=\"elementor-heading-title elementor-size-default\">D\u00e9couverte et port\u00e9e<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-aceb77b elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"aceb77b\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Animer des ateliers de d\u00e9couverte cibl\u00e9s et recueillir des preuves avec vos experts en la mati\u00e8re : confirmer l'objectif vis\u00e9, les variantes de dispositifs, le contenu existant du RMF, les ensembles de preuves \u00e0 l'appui (V&amp;V, clinique, biocompatibilit\u00e9, utilisabilit\u00e9) et les signaux PMS que seule votre \u00e9quipe est en mesure de fournir.<\/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 class=\"elementor-element elementor-element-521e6d9 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"521e6d9\" 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>\n\t\t<div class=\"elementor-element elementor-element-56e3695 e-con-full e-flex e-con e-child\" data-id=\"56e3695\" 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-4010908 elementor-widget elementor-widget-heading\" data-id=\"4010908\" 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\">02<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5c8b969 elementor-widget elementor-widget-heading\" data-id=\"5c8b969\" 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<h4 class=\"elementor-heading-title elementor-size-default\">\u00c9tendre les dangers et structurer les tableaux de risques<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a6f4597 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"a6f4597\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Avec vos experts, \u00e9largissez la couverture des dangers et les abus pr\u00e9visibles, puis structurez les tableaux d'estimation et d'\u00e9valuation des risques conform\u00e9ment \u00e0 la norme ISO 14971 et aux attentes des RMD, en refl\u00e9tant vos crit\u00e8res d'acceptation et vos politiques en mati\u00e8re de risques.<\/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 class=\"elementor-element elementor-element-5483315 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"5483315\" 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>\n\t\t<div class=\"elementor-element elementor-element-d9e2645 e-con-full e-flex e-con e-child\" data-id=\"d9e2645\" 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-f7df8af elementor-widget elementor-widget-heading\" data-id=\"f7df8af\" 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\">03<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7ea644a elementor-widget elementor-widget-heading\" data-id=\"7ea644a\" 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<h4 class=\"elementor-heading-title elementor-size-default\">D\u00e9finir les contr\u00f4les et r\u00e9diger des r\u00e9cits<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-70b7dbf elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"70b7dbf\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Travaillez avec votre \u00e9quipe pour d\u00e9finir et v\u00e9rifier les contr\u00f4les des risques (conception, processus, informations relatives \u00e0 la s\u00e9curit\u00e9), puis r\u00e9digez des descriptions des risques r\u00e9siduels et des avantages globaux des risques que vos parties prenantes internes examinent et affinent avant de les approuver.<\/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 class=\"elementor-element elementor-element-49241e8 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"49241e8\" 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>\n\t\t<div class=\"elementor-element elementor-element-2e5ea42 e-con-full e-flex e-con e-child\" data-id=\"2e5ea42\" 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-eabc231 elementor-widget elementor-widget-heading\" data-id=\"eabc231\" 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\">04<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-714fa96 elementor-widget elementor-widget-heading\" data-id=\"714fa96\" 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<h4 class=\"elementor-heading-title elementor-size-default\">Cartographier les GSPR et les interfaces<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6717b1f elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"6717b1f\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">\u00c9laborer une matrice de correspondance GSPR concise (annexe I) en utilisant votre documentation existante et documenter les interfaces entre le RMF, le CER, le BER\/TRA, l'utilisabilit\u00e9, l'IFU\/label et le PMS afin que la tra\u00e7abilit\u00e9 soit claire et qu'elle refl\u00e8te votre ensemble de fichiers r\u00e9el.<\/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 class=\"elementor-element elementor-element-0dbd363 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"0dbd363\" 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>\n\t\t<div class=\"elementor-element elementor-element-6c3535b e-con-full e-flex e-con e-child\" data-id=\"6c3535b\" 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-0c30aa6 elementor-widget elementor-widget-heading\" data-id=\"0c30aa6\" 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\">05<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e716650 elementor-widget elementor-widget-heading\" data-id=\"e716650\" 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<h4 class=\"elementor-heading-title elementor-size-default\">Maintenance et transfert<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-905d12f elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"905d12f\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Nous accompagnons la structure du RMF actualis\u00e9e d'un journal des modifications et d'une cadence de r\u00e9vision pratique li\u00e9e au PMS, nous convenons des d\u00e9clencheurs et des propri\u00e9taires avec votre \u00e9quipe et nous vous remettons un ensemble de fichiers faciles \u00e0 maintenir, que vous pouvez exploiter et mettre \u00e0 jour.<\/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 class=\"elementor-element elementor-element-3db7929 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"3db7929\" 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>\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-2be8160 animated-slow e-con-full e-flex elementor-invisible e-con e-parent\" data-id=\"2be8160\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a3e414c elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"a3e414c\" 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\">Ce que nous attendons de vous<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5b3e47a elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-text-editor\" data-id=\"5b3e47a\" 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 rely on you for facts about your business and devices; we provide structure and guidance.\"}]\" data-inline-monday=\"true\">Nous nous appuyons sur vous pour obtenir des informations sur votre entreprise et vos appareils ; nous vous fournissons une structure et des conseils.<\/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-817ffaf e-flex e-con-boxed e-con e-child\" data-id=\"817ffaf\" 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-bff56ec e-con-full e-flex e-con e-child\" data-id=\"bff56ec\" 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-9394595 elementor-widget__width-inherit elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"9394595\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Objectif vis\u00e9, description du dispositif et variantes\/configurations telles que d\u00e9finies par votre \u00e9quipe.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Cadre de r\u00e9f\u00e9rence existant (le cas \u00e9ch\u00e9ant) et preuves sous-jacentes : rapports de v\u00e9rification et de validation, \u00e9valuation clinique, biocompatibilit\u00e9, facilit\u00e9 d'utilisation, logiciels, etc.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Signaux PMS que vous collectez : plaintes, cas de vigilance, rapports de tendance et autres donn\u00e9es 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Vos crit\u00e8res d'acceptation actuels ou vos politiques de risque (le cas \u00e9ch\u00e9ant) pour guider l'\u00e9valuation et la prise de d\u00e9cision.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">IFU et extraits d'\u00e9tiquettes que vous utilisez pour communiquer les risques et les risques r\u00e9siduels aux utilisateurs.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Acc\u00e8s \u00e0 des experts internes comp\u00e9tents (par exemple, cliniciens, ing\u00e9nieurs, responsables de la qualit\u00e9) pour confirmer les sc\u00e9narios, les contr\u00f4les et les justifications.<\/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 class=\"elementor-element elementor-element-9458a77 elementor-widget elementor-widget-text-editor\" data-id=\"9458a77\" 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\":\"Consulting and documentation for risk management only. We cannot create a complete RMF in isolation; we rely on your experts, evidence, and policies. We do not act as a notified body, importer, or legal counsel. The Legal Manufacturer remains responsible for final decisions, RMF approval, and all formal submissions and communications with authorities and Notified Bodies.\"}]\" data-inline-monday=\"true\"><strong>Conseil et documentation pour la gestion des risques uniquement. Nous ne pouvons pas cr\u00e9er un CMR complet de mani\u00e8re isol\u00e9e ; nous nous appuyons sur vos experts, vos preuves et vos politiques. Nous n&rsquo;agissons pas en tant qu&rsquo;organisme notifi\u00e9, importateur ou conseiller juridique. Le fabricant l\u00e9gal reste responsable des d\u00e9cisions finales, de l&rsquo;approbation du CMR et de toutes les soumissions et communications formelles avec les autorit\u00e9s et les organismes notifi\u00e9s.   <\/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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ef0084e e-flex e-con-boxed e-con e-parent\" data-id=\"ef0084e\" 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-a7bba34 elementor-widget elementor-widget-heading\" data-id=\"a7bba34\" 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\">QUESTIONS FR\u00c9QUEMMENT POS\u00c9ES<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bc8de9e elementor-widget elementor-widget-toggle\" data-id=\"bc8de9e\" 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-1971\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1971\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Sobel peut-il cr\u00e9er le dossier complet de gestion des risques sans que nous ayons \u00e0 fournir beaucoup d'informations ?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1971\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1971\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" No. We provide the structure, drafting support, and regulatory alignment, but the RMF relies on your device knowledge, internal policies, and evidence. Your team must participate in workshops, supply documentation, and make the risk decisions that we then document.\"}]\" data-inline-monday=\"true\">Nous fournissons la structure, l&rsquo;aide \u00e0 la r\u00e9daction et l&rsquo;alignement r\u00e9glementaire, mais le RMF s&rsquo;appuie sur votre connaissance des dispositifs, vos politiques internes et vos preuves. Votre \u00e9quipe doit participer \u00e0 des ateliers, fournir de la documentation et prendre des d\u00e9cisions en mati\u00e8re de risque que nous documentons ensuite.  <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1972\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-1972\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Agissez-vous en tant qu'organisme notifi\u00e9, importateur ou conseiller juridique pour la gestion des risques ?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1972\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-1972\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" No. We provide consulting and documentation services only. We help structure and write the RMF and related mappings; the Legal Manufacturer retains responsibility for decisions, approvals, and all formal submissions and communications.\"}]\" data-inline-monday=\"true\">Non. Nous fournissons uniquement des services de conseil et de documentation. Nous aidons \u00e0 structurer et \u00e0 r\u00e9diger le RMF et les cartographies correspondantes ; le fabricant juridique conserve la responsabilit\u00e9 des d\u00e9cisions, des approbations et de toutes les soumissions et communications formelles.  <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1973\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-1973\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Sur quelles normes et orientations alignez-vous le RMF ?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1973\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-1973\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" We align the RMF with MDR risk management expectations and ISO 14971. Where applicable, we consider EN ISO 14971:2019 + A11:2021 for harmonized alignment and ISO\/TR 24971:2020 for practical lifecycle guidance, always adapted to your device and evidence.\"}]\" data-inline-monday=\"true\">Nous alignons le RMF sur les attentes du MDR en mati\u00e8re de gestion des risques et sur la norme ISO 14971. Le cas \u00e9ch\u00e9ant, nous prenons en compte la norme EN ISO 14971:2019 + A11:2021 pour un alignement harmonis\u00e9 et la norme ISO\/TR 24971:2020 pour des conseils pratiques sur le cycle de vie, toujours adapt\u00e9s \u00e0 votre dispositif et \u00e0 vos preuves. <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1974\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-1974\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">G\u00e9n\u00e8rez-vous de nouvelles donn\u00e9es de test pour le RMF ?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1974\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-1974\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" No. We work from the verification, validation, clinical, biocompatibility, usability, and PMS data you provide. We can highlight where additional testing or analysis may be justified, but you decide and commission any new studies.\"}]\" data-inline-monday=\"true\">Nous travaillons \u00e0 partir des donn\u00e9es de v\u00e9rification, de validation, cliniques, de biocompatibilit\u00e9, d&rsquo;utilisabilit\u00e9 et de PMS que vous nous fournissez. Nous pouvons mettre en \u00e9vidence les domaines dans lesquels des essais ou des analyses suppl\u00e9mentaires peuvent \u00eatre justifi\u00e9s, mais c&rsquo;est vous qui d\u00e9cidez et qui commandez les nouvelles \u00e9tudes.  <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1975\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-1975\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Comment le RMF est-il reli\u00e9 aux GSPR et aux PMS dans la pratique ?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1975\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-1975\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" Using your documentation and PMS processes, we build a GSPR mapping matrix that links Annex I requirements to risks, controls, and evidence, and we issue a maintenance mini-plan so RMF updates are triggered by your PMS outputs and other lifecycle changes.\"}]\" data-inline-monday=\"true\">\u00c0 l&rsquo;aide de votre documentation et de vos processus PMS, nous \u00e9laborons une matrice de correspondance GSPR qui relie les exigences de l&rsquo;annexe I aux risques, aux contr\u00f4les et aux preuves, et nous \u00e9mettons un mini-plan de maintenance afin que les mises \u00e0 jour du RMF soient d\u00e9clench\u00e9es par les r\u00e9sultats de votre PMS et d&rsquo;autres changements dans le cycle de vie.<\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1976\" class=\"elementor-tab-title\" data-tab=\"6\" role=\"button\" aria-controls=\"elementor-tab-content-1976\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Ce service s'applique-t-il aux fabricants \u00e9trangers et aux agents am\u00e9ricains ?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1976\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"6\" role=\"region\" aria-labelledby=\"elementor-tab-title-1976\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\" No. This service is specifically for U.S.-based establishments. Concepts like a \u201cU.S. Agent\u201d are relevant for foreign establishments, not for U.S. companies.\"}]\" data-inline-monday=\"true\">Non. Ce service s&rsquo;adresse sp\u00e9cifiquement aux \u00e9tablissements bas\u00e9s aux \u00c9tats-Unis. Les concepts tels que celui d'\u00a0\u00bbagent am\u00e9ricain\u00a0\u00bb s&rsquo;appliquent aux \u00e9tablissements \u00e9trangers et non aux entreprises am\u00e9ricaines.  <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-64211c5 elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile e-flex e-con-boxed e-con e-parent\" data-id=\"64211c5\" 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-bdc3425 e-con-full e-flex e-con e-child\" data-id=\"bdc3425\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e86daa6 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"e86daa6\" 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\">Glossaire abr\u00e9g\u00e9<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-98308b9 elementor-align-left borda-piscando elementor-widget elementor-widget-button\" data-id=\"98308b9\" 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 elementor-animation-pulse\" href=\"#cta\">\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-far-envelope\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 64H48C21.49 64 0 85.49 0 112v288c0 26.51 21.49 48 48 48h416c26.51 0 48-21.49 48-48V112c0-26.51-21.49-48-48-48zm0 48v40.805c-22.422 18.259-58.168 46.651-134.587 106.49-16.841 13.247-50.201 45.072-73.413 44.701-23.208.375-56.579-31.459-73.413-44.701C106.18 199.465 70.425 171.067 48 152.805V112h416zM48 400V214.398c22.914 18.251 55.409 43.862 104.938 82.646 21.857 17.205 60.134 55.186 103.062 54.955 42.717.231 80.509-37.199 103.053-54.947 49.528-38.783 82.032-64.401 104.947-82.653V400H48z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Parler \u00e0 Sobel<\/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-d952655 e-con-full e-flex e-con e-child\" data-id=\"d952655\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0358248 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"0358248\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>Propri\u00e9taire\/Op\u00e9rateur (O\/O) :<\/strong> Le compte de l'entit\u00e9 juridique utilis\u00e9e pour acc\u00e9der \u00e0 FURLS et g\u00e9rer les informations relatives \u00e0 l'enregistrement et \u00e0 l'inscription.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>FURLS (FDA Unified Registration and Listing System) :<\/strong> Le syst\u00e8me de compte en ligne de la FDA pour l'enregistrement et l'inscription.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>DRLM (Device Registration &amp; Listing Module) :<\/strong> Le module FURLS utilis\u00e9 sp\u00e9cifiquement pour l'enregistrement des \u00e9tablissements de dispositifs m\u00e9dicaux et l'\u00e9tablissement de listes de dispositifs.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>Enregistrement et inscription initiaux :<\/strong> Le premier enregistrement et la premi\u00e8re inscription d'un \u00e9tablissement de dispositifs, requis dans les 30 jours suivant le d\u00e9but des activit\u00e9s li\u00e9es aux dispositifs.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>R\u00e9vision annuelle (oct-d\u00e9c) :<\/strong> La p\u00e9riode annuelle requise pour v\u00e9rifier et mettre \u00e0 jour l'enregistrement et les listes et pour payer les frais d'utilisation de l'enregistrement de l'\u00e9tablissement.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>Pas une approbation :<\/strong> Nous vous rappelons que l'enregistrement et l'inscription sur la liste ne sont pas synonymes d'approbation ou d'autorisation de la FDA.<\/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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6cbfe14 e-flex e-con-boxed e-con e-parent\" data-id=\"6cbfe14\" 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-83bf13c e-con-full e-flex e-con e-child\" data-id=\"83bf13c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f04a963 elementor-widget elementor-widget-image\" data-id=\"f04a963\" 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=\"1920\" height=\"2560\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-scaled.jpg\" class=\"attachment-full size-full wp-image-15581\" alt=\"A woman holding a smartphone in one hand and a stethoscope in the other. She wears medical gloves and appears to be in a hospital setting. Regulatory Medical Device Consultancy.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-scaled.jpg 1920w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-225x300.jpg 225w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-768x1024.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-1152x1536.jpg 1152w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/img2-1536x2048.jpg 1536w\" sizes=\"(max-width: 1920px) 100vw, 1920px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-999d43d e-con-full e-flex e-con e-child\" data-id=\"999d43d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4580ec5 elementor-widget elementor-widget-heading\" data-id=\"4580ec5\" 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\">Construire mon dossier de gestion des risques<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e0a00a7 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"e0a00a7\" 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\u2019ll reply with a proposed slot and a short intake checklist so we can confirm your current RMF status, available evidence, and who from your team should join the workshops.\"}]\" data-inline-monday=\"true\">Nous vous r\u00e9pondrons en vous proposant un cr\u00e9neau horaire et une br\u00e8ve liste de contr\u00f4le afin que nous puissions confirmer votre statut actuel de RMF, les preuves disponibles et les personnes de votre \u00e9quipe qui devraient participer aux ateliers.<\/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-3861d13 elementor-align-left borda-piscando elementor-widget elementor-widget-button\" data-id=\"3861d13\" 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 elementor-animation-pulse\" href=\"#cta\">\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-far-envelope\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 64H48C21.49 64 0 85.49 0 112v288c0 26.51 21.49 48 48 48h416c26.51 0 48-21.49 48-48V112c0-26.51-21.49-48-48-48zm0 48v40.805c-22.422 18.259-58.168 46.651-134.587 106.49-16.841 13.247-50.201 45.072-73.413 44.701-23.208.375-56.579-31.459-73.413-44.701C106.18 199.465 70.425 171.067 48 152.805V112h416zM48 400V214.398c22.914 18.251 55.409 43.862 104.938 82.646 21.857 17.205 60.134 55.186 103.062 54.955 42.717.231 80.509-37.199 103.053-54.947 49.528-38.783 82.032-64.401 104.947-82.653V400H48z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Voir un exemple de structure RMF<\/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-45b405b e-flex e-con-boxed e-con e-parent\" data-id=\"45b405b\" data-element_type=\"container\" data-e-type=\"container\" id=\"cta\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-6b86a0c e-con-full e-flex e-con e-child\" data-id=\"6b86a0c\" 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-8c37394 elementor-align-center elementor-widget elementor-widget-lottie\" data-id=\"8c37394\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;source_json&quot;:{&quot;url&quot;:&quot;https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2025\\\/10\\\/Contact-us.json&quot;,&quot;id&quot;:16710,&quot;size&quot;:&quot;&quot;,&quot;alt&quot;:&quot;&quot;,&quot;source&quot;:&quot;library&quot;},&quot;loop&quot;:&quot;yes&quot;,&quot;source&quot;:&quot;media_file&quot;,&quot;caption_source&quot;:&quot;none&quot;,&quot;link_to&quot;:&quot;none&quot;,&quot;trigger&quot;:&quot;arriving_to_viewport&quot;,&quot;viewport&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:0,&quot;end&quot;:100}},&quot;play_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:1,&quot;sizes&quot;:[]},&quot;start_point&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;end_point&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:100,&quot;sizes&quot;:[]},&quot;renderer&quot;:&quot;svg&quot;}\" data-widget_type=\"lottie.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"e-lottie__container\"><div class=\"e-lottie__animation\"><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d893367 e-con-full e-flex e-con e-child\" data-id=\"d893367\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-cbc7c33 elementor-widget elementor-widget-heading\" data-id=\"cbc7c33\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Contactez nous<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7bd248d elementor-widget elementor-widget-heading\" data-id=\"7bd248d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Nous serions ravis de parler avec vous.<br>N'h\u00e9sitez pas \u00e0 nous contacter en utilisant les coordonn\u00e9es ci-dessous.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8ec8767 elementor-widget__width-initial elementor-button-align-stretch elementor-widget elementor-widget-form\" data-id=\"8ec8767\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;step_next_label&quot;:&quot;Suivant&quot;,&quot;step_previous_label&quot;:&quot;Pr\\u00e9c\\u00e9dent&quot;,&quot;button_width&quot;:&quot;100&quot;,&quot;step_type&quot;:&quot;number_text&quot;,&quot;step_icon_shape&quot;:&quot;circle&quot;}\" data-widget_type=\"form.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<form class=\"elementor-form\" method=\"post\" id=\"form_lp_eu_iso14971_risk_eng\" name=\"Formulaire de contact - eu_iso14971_risk_eng\" aria-label=\"Formulaire de contact - eu_iso14971_risk_eng\">\n\t\t\t<input type=\"hidden\" name=\"post_id\" value=\"22175\"\/>\n\t\t\t<input type=\"hidden\" name=\"form_id\" value=\"8ec8767\"\/>\n\t\t\t<input type=\"hidden\" name=\"referer_title\" value=\"Sobel\" \/>\n\n\t\t\t\n\t\t\t<div class=\"elementor-form-fields-wrapper elementor-labels-above\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-first_name elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-first_name\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tNom complet\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[first_name]\" id=\"form-field-first_name\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Tapez ici\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-email elementor-field-group elementor-column elementor-field-group-email elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-email\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tAdresse \u00e9lectronique\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"email\" name=\"form_fields[email]\" id=\"form-field-email\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Tapez ici\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-tel elementor-field-group elementor-column elementor-field-group-phone elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-phone\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tNum\u00e9ro de t\u00e9l\u00e9phone\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t<input size=\"1\" type=\"tel\" name=\"form_fields[phone]\" id=\"form-field-phone\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Tapez ici\" required=\"required\" pattern=\"[0-9()#&amp;+*-=.]+\" title=\"Seuls les caract\u00e8res de num\u00e9ros de t\u00e9l\u00e9phone (#, -, *, etc.) sont accept\u00e9s.\">\n\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-company elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-company\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tEntreprise\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[company]\" id=\"form-field-company\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Tapez ici\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-textarea elementor-field-group elementor-column elementor-field-group-message elementor-col-100 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-message\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tMessage\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t<textarea class=\"elementor-field-textual elementor-field  elementor-size-sm\" name=\"form_fields[message]\" id=\"form-field-message\" rows=\"4\" placeholder=\"Tapez ici\" required=\"required\"><\/textarea>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-acceptance elementor-field-group elementor-column elementor-field-group-privacyagreed elementor-col-100 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t<div class=\"elementor-field-subgroup\">\n\t\t\t<span class=\"elementor-field-option\">\n\t\t\t\t<input type=\"checkbox\" name=\"form_fields[privacyagreed]\" id=\"form-field-privacyagreed\" class=\"elementor-field elementor-size-sm  elementor-acceptance-field\" required=\"required\">\n\t\t\t\t<label for=\"form-field-privacyagreed\">&nbsp;&nbsp;  J'accepte la d\u00e9claration de confidentialit\u00e9 des donn\u00e9es et les conditions g\u00e9n\u00e9rales publi\u00e9es sur ce site.<\/label>\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-acceptance elementor-field-group elementor-column elementor-field-group-newslettercheck elementor-col-100\">\n\t\t\t\t\t\t\t<div class=\"elementor-field-subgroup\">\n\t\t\t<span class=\"elementor-field-option\">\n\t\t\t\t<input type=\"checkbox\" name=\"form_fields[newslettercheck]\" id=\"form-field-newslettercheck\" class=\"elementor-field elementor-size-sm  elementor-acceptance-field\">\n\t\t\t\t<label for=\"form-field-newslettercheck\">&nbsp; &nbsp;J'accepte de recevoir des bulletins d'information bihebdomadaires contenant des mises \u00e0 jour sur le march\u00e9 r\u00e9glementaire mondial.<\/label>\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_source elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_source]\" id=\"form-field-utm_source\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_campaign elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_campaign]\" id=\"form-field-utm_campaign\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_adgroupname elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_adgroupname]\" id=\"form-field-utm_adgroupname\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_term elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_term]\" id=\"form-field-utm_term\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-gclid elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[gclid]\" id=\"form-field-gclid\" class=\"elementor-field elementor-size-sm  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class=\"elementor-element elementor-element-ffd72ee elementor-widget elementor-widget-heading\" data-id=\"ffd72ee\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/sobelconsult.com\/fr\/declaration-de-confidentialite-us\/\" target=\"_blank\">Politique de confidentialit\u00e9<\/a><\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Parler \u00e0 Sobel Union europ\u00e9enne - Gestion des risques (ISO 14971 \/ MDR) Dossier de gestion des risques - ISO 14971 \/ MDR align\u00e9 En vertu du r\u00e8glement europ\u00e9en sur les m\u00e9dicaments, les fabricants doivent \u00e9tablir, documenter, mettre en \u0153uvre et tenir \u00e0 jour un syst\u00e8me de gestion des risques. Le dossier de gestion des [&hellip;]<\/p>\n","protected":false},"author":15,"featured_media":0,"parent":15869,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_canvas","meta":{"footnotes":""},"class_list":["post-22175","page","type-page","status-publish","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>Dossier de gestion des risques (ISO 14971 \/ MDR) | Co-d\u00e9velopp\u00e9 avec votre \u00e9quipe<\/title>\n<meta name=\"description\" content=\"Sobel structure et d\u00e9veloppe avec vos experts un dossier de gestion des risques conforme \u00e0 la norme ISO 14971 \/ MDR : ateliers de d\u00e9couverte, expansion des dangers, tableaux des risques, projets de narration des risques r\u00e9siduels, cartographie GSPR et plan de maintenance li\u00e9 au PMS - les d\u00e9cisions finales restent du ressort du fabricant l\u00e9gal.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sobelconsult.com\/fr\/materiais\/eu-iso14971-risk\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dossier de gestion des risques (ISO 14971 \/ MDR) | Co-d\u00e9velopp\u00e9 avec votre \u00e9quipe\" \/>\n<meta property=\"og:description\" content=\"Sobel structure et d\u00e9veloppe avec vos experts un dossier de gestion des risques conforme \u00e0 la norme ISO 14971 \/ MDR : ateliers de d\u00e9couverte, expansion des dangers, tableaux des risques, projets de narration des risques r\u00e9siduels, cartographie GSPR et plan de maintenance li\u00e9 au PMS - 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