{"id":51616,"date":"2024-05-28T12:52:11","date_gmt":"2024-05-28T17:52:11","guid":{"rendered":"https:\/\/nimonik.com\/?page_id=51616"},"modified":"2026-05-22T11:09:49","modified_gmt":"2026-05-22T16:09:49","slug":"dispositifs-medicaux","status":"publish","type":"page","link":"https:\/\/nimonik.com\/fr\/industries-2\/dispositifs-medicaux\/","title":{"rendered":"Dispositifs m\u00e9dicaux"},"content":{"rendered":"<div class=\"gb-container gb-container-3ebf944a\"><div class=\"gb-inside-container\">\n<div class=\"gb-grid-wrapper gb-grid-wrapper-0b65ff28\">\n<div class=\"gb-grid-column gb-grid-column-e3caf97f\"><div class=\"gb-container gb-container-e3caf97f\"><div class=\"gb-inside-container\">\n\n<div class=\"gb-headline gb-headline-3f2906de gb-headline-text\">Industrie des dispositifs m\u00e9dicaux<\/div>\n\n\n\n<h1 class=\"gb-headline gb-headline-69385dc7 gb-headline-text\"><strong><strong><strong>Conformit\u00e9 compl\u00e8te et abordable pour les dispositifs m\u00e9dicaux<\/strong><\/strong><\/strong><\/h1>\n\n\n\n<p class=\"gb-headline gb-headline-4642df67 gb-headline-text\">Nimonik accompagne le secteur des dispositifs m\u00e9dicaux en offrant acc\u00e8s aux normes industrielles essentielles ainsi qu&rsquo;aux informations r\u00e9glementaires et aux mises \u00e0 jour n\u00e9cessaires pour soutenir le d\u00e9veloppement des produits, leur homologation et les activit\u00e9s de conformit\u00e9 continue.<\/p>\n\n\n<div class=\"gb-button-wrapper gb-button-wrapper-6ed71d4a\">\n\n<a class=\"gb-button gb-button-bc98bef8 gb-button-text smooth-scroll\" href=\"https:\/\/nimonik.com\/fr\/request-a-demo\/\" target=\"_blank\" rel=\"noopener noreferrer\">Planifier une d\u00e9monstration<\/a>\n\n<\/div>\n<\/div><\/div><\/div>\n<\/div>\n<\/div><div class=\"gb-shapes\"><div class=\"gb-shape gb-shape-1\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 1200 360\" preserveAspectRatio=\"none\"><path d=\"M1200 360H0V0l1200 348z\"\/><\/svg><\/div><\/div><\/div>\n\n\n<div class=\"wp-block-columns are-vertically-aligned-center is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:100%\"><div class=\"gb-container gb-container-743bbb84\"><div class=\"gb-inside-container\">\n<div class=\"gb-grid-wrapper gb-grid-wrapper-fa0bf2a6\">\n<div class=\"gb-grid-column gb-grid-column-ea71fc67\"><div class=\"gb-container gb-container-ea71fc67\"><div class=\"gb-inside-container\">\n\n<figure class=\"gb-block-image gb-block-image-120488d4\"><img decoding=\"async\" width=\"2560\" height=\"2338\" class=\"gb-image gb-image-120488d4\" src=\"https:\/\/nimonik.com\/wp-content\/uploads\/Nimonik_Medical_Device_Subscription_Packages_Image-scaled.png\" alt=\"\" title=\"Nimonik_Medical_Device_Subscription_Packages_Image\" srcset=\"https:\/\/nimonik.com\/wp-content\/uploads\/Nimonik_Medical_Device_Subscription_Packages_Image-scaled.png 2560w, https:\/\/nimonik.com\/wp-content\/uploads\/Nimonik_Medical_Device_Subscription_Packages_Image-300x274.png 300w, https:\/\/nimonik.com\/wp-content\/uploads\/Nimonik_Medical_Device_Subscription_Packages_Image-1024x935.png 1024w, https:\/\/nimonik.com\/wp-content\/uploads\/Nimonik_Medical_Device_Subscription_Packages_Image-1536x1403.png 1536w, https:\/\/nimonik.com\/wp-content\/uploads\/Nimonik_Medical_Device_Subscription_Packages_Image-2048x1871.png 2048w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/figure>\n\n<\/div><\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-8f34168a\"><div class=\"gb-container gb-container-8f34168a\"><div class=\"gb-inside-container\">\n\n<h2 class=\"wp-block-heading\"><strong>Couverture compl\u00e8te des normes de l&rsquo;industrie des dispositifs m\u00e9dicaux<\/strong><\/h2>\n\n\n\n<p>Les clients du secteur des dispositifs m\u00e9dicaux peuvent b\u00e9n\u00e9ficier d&rsquo;une couverture compl\u00e8te des normes industrielles requises en cr\u00e9ant des collections d&rsquo;abonnements personnalis\u00e9es avec Nimonik. Nimonik \u00e9tant un distributeur officiel de l&rsquo;ASTM International et de plus de 90 organismes de normalisation, les utilisateurs peuvent acc\u00e9der aux normes ASTM ainsi qu&rsquo;\u00e0 d&rsquo;autres normes sur une seule et m\u00eame plateforme. Plus besoin d&rsquo;acc\u00e9der \u00e0 ASTM Compass ni de passer d&rsquo;une plateforme \u00e0 l&rsquo;autre.<\/p>\n\n\n\n<p>Tout en acc\u00e9dant aux documents cl\u00e9s, les utilisateurs peuvent tirer parti d\u2019outils et de fonctionnalit\u00e9s de workflow puissants pour exploiter au mieux leurs normes. La plateforme de Nimonik inclut des mises \u00e0 jour gratuites, des outils de comparaison de documents, des rapports d\u2019utilisation, des fonctionnalit\u00e9s d\u2019audit et bien plus encore ! De plus, les utilisateurs peuvent associer les normes \u00e0 des \u00e9l\u00e9ments op\u00e9rationnels, ce qui permet aux \u00e9quipes d\u2019examiner de mani\u00e8re proactive les changements et d\u2019attribuer des t\u00e2ches aux membres concern\u00e9s.<\/p>\n\n<\/div><\/div><\/div>\n<\/div>\n<\/div><\/div><\/div>\n<\/div>\n\n\n\n<div style=\"height:44px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"gb-container gb-container-cf289dba\">\n<div class=\"gb-container gb-container-d2ef80f2\">\n\n<h2 class=\"wp-block-heading has-text-align-center\"><strong><strong>Principaux organismes de normalisation (SDOs) du secteur des dispositifs m\u00e9dicaux chez Nimonik<\/strong><\/strong><\/h2>\n\n\n\n<div style=\"height:22px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" width=\"1191\" height=\"318\" src=\"https:\/\/nimonik.com\/wp-content\/uploads\/Nimonik_Medical-Device_SDOs-2.png\" alt=\"\" class=\"wp-image-60487\" srcset=\"https:\/\/nimonik.com\/wp-content\/uploads\/Nimonik_Medical-Device_SDOs-2.png 1191w, https:\/\/nimonik.com\/wp-content\/uploads\/Nimonik_Medical-Device_SDOs-2-300x80.png 300w, https:\/\/nimonik.com\/wp-content\/uploads\/Nimonik_Medical-Device_SDOs-2-1024x273.png 1024w\" sizes=\"(max-width: 1191px) 100vw, 1191px\" \/><\/figure>\n<\/div>\n<\/div>\n<\/div>\n\n<div class=\"gb-container gb-container-494e01a4\"><div class=\"gb-inside-container\">\n\n<div style=\"height:140px\" aria-hidden=\"true\" id=\"nimonik-pricing-plans\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-media-text has-media-on-the-right is-stacked-on-mobile\" style=\"grid-template-columns:auto 61%\"><div class=\"wp-block-media-text__content\">\n<h2 class=\"wp-block-heading\"><strong><strong>Acc\u00e8s abordable aux normes<\/strong><\/strong><\/h2>\n\n\n\n<p>Nimonik propose un ensemble de normes industrielles \u00e0 prix avantageux destin\u00e9 aux petites et moyennes entreprises du secteur des dispositifs m\u00e9dicaux qui souhaitent acc\u00e9der aux normes ISO et IEC essentielles \u00e0 ce secteur, ainsi qu&rsquo;aux outils et fonctionnalit\u00e9s de base de la plateforme. Con\u00e7ues pour les entreprises \u00e9mergentes du secteur des dispositifs m\u00e9dicaux \u00e0 travers le monde, les normes incluses dans cette offre tr\u00e8s abordable ne sont pas limit\u00e9es \u00e0 un site particulier et sont disponibles en fran\u00e7ais, en anglais ou en allemand.<\/p>\n<\/div><figure class=\"wp-block-media-text__media\"><img decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/nimonik.com\/wp-content\/uploads\/anastassia-anufrieva-JUlfa5fAIg-unsplash-1024x683.jpg\" alt=\"\" class=\"wp-image-60262 size-full\" srcset=\"https:\/\/nimonik.com\/wp-content\/uploads\/anastassia-anufrieva-JUlfa5fAIg-unsplash-1024x683.jpg 1024w, https:\/\/nimonik.com\/wp-content\/uploads\/anastassia-anufrieva-JUlfa5fAIg-unsplash-300x200.jpg 300w, https:\/\/nimonik.com\/wp-content\/uploads\/anastassia-anufrieva-JUlfa5fAIg-unsplash-1536x1024.jpg 1536w, https:\/\/nimonik.com\/wp-content\/uploads\/anastassia-anufrieva-JUlfa5fAIg-unsplash.jpg 1920w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure><\/div>\n\n\n\n<div style=\"height:66px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><strong><strong><strong>Forfait de normes essentielles pour les dispositifs m\u00e9dicaux<\/strong><\/strong><\/strong><\/h2>\n\n\n\n<p>Acc\u00e9dez aux normes EN-ISO et EN-IEC les plus importantes pour les organismes du secteur des dispositifs m\u00e9dicaux gr\u00e2ce \u00e0 deux collections \u00e0 prix abordable. Ces normes essentielles sont fr\u00e9quemment cit\u00e9es dans les cadres r\u00e9glementaires et jouent un r\u00f4le important dans le d\u00e9veloppement des produits, l&rsquo;\u00e9valuation des risques et les demandes d&rsquo;autorisation r\u00e9glementaire. Les clients peuvent \u00e0 tout moment ajouter d&rsquo;autres normes \u00e0 leur abonnement afin de r\u00e9pondre \u00e0 leurs besoins suppl\u00e9mentaires.<\/p>\n\n\n\n<div style=\"height:22px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h5 class=\"wp-block-heading\"><strong>EN ISO : Forfait pour les dispositifs m\u00e9dicaux<\/strong><\/h5>\n\n\n<div class=\"gb-grid-wrapper gb-grid-wrapper-c03198b2\">\n<div class=\"gb-grid-column gb-grid-column-39c86f14\"><div class=\"gb-container gb-container-39c86f14\">\n\n<ul class=\"wp-block-list\">\n<li class=\"has-medium-font-size\"><strong><strong>Gestion de la qualit\u00e9 et gestion des risques<\/strong><\/strong><\/li>\n\n\n\n<li>EN-ISO 13485 \u2014 Medical devices quality management systems<\/li>\n\n\n\n<li>EN-ISO 14971 \u2014 Application of risk management to medical devices<\/li>\n\n\n\n<li>EN-ISO 24971 \u2014 Guidance on the application of ISO 14971<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"has-medium-font-size\"><strong><strong>Biocompatibilit\u00e9<\/strong><\/strong><\/li>\n\n\n\n<li>EN-ISO 10993 Series \u2014 Biological evaluation of medical devices\n<ul class=\"wp-block-list\">\n<li>Inclut EN-ISO 10993-1, EN-ISO 10993-5, et EN-ISO 10993-10<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"has-medium-font-size\"><strong><strong>Proc\u00e9d\u00e9s de st\u00e9rilisation<\/strong><\/strong><\/li>\n\n\n\n<li>EN-ISO 11135 \u2014 Ethylene oxide sterilization requirements<\/li>\n\n\n\n<li>EN-ISO 11137 Series \u2014 Sterilization of health care products\n<ul class=\"wp-block-list\">\n<li>Inclut EN-ISO 11137-1, EN-ISO 11137-2, EN-ISO 11137-3, et EN-ISO 11137-4<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>EN-ISO 11138 Series \u2014 Requirements for Biological Indicators\n<ul class=\"wp-block-list\">\n<li>Inclut EN-ISO 11138-1, EN-ISO 11138-2, EN-ISO 11138-3, EN-ISO 11138-4, EN-ISO 11138-5, et EN-ISO 11138-7<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-1a600f2a\"><div class=\"gb-container gb-container-1a600f2a\">\n\n<ul class=\"wp-block-list\">\n<li class=\"has-medium-font-size\"><strong><strong>Emballage et environnements contr\u00f4l\u00e9s<\/strong><\/strong><\/li>\n\n\n\n<li>EN-ISO 11607 Series \u2014 Packaging for terminally sterilized medical devices\n<ul class=\"wp-block-list\">\n<li>Inclut EN-ISO 11607-1 et EN-ISO 11607-2<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>EN-ISO 14644 Series \u2014 Cleanrooms and associated controlled environments\n<ul class=\"wp-block-list\">\n<li>Inclut EN-ISO 14644-1, EN-ISO 14644-2, EN-ISO 14644-3, et EN-ISO 14644-4<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"has-medium-font-size\"><strong><strong>\u00c9tiquetage et informations du fabricant<\/strong><\/strong><\/li>\n\n\n\n<li>EN-ISO 15223 Series \u2014 Symbols to be used with medical device labels\n<ul class=\"wp-block-list\">\n<li>Inclut EN-ISO 15223-1 et EN-ISO 15223-2&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>EN-ISO 20417 \u2014 Information supplied by the manufacturer<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"has-medium-font-size\"><strong><strong><strong>Donn\u00e9es cliniques<\/strong><\/strong><\/strong><\/li>\n\n\n\n<li>EN-ISO 14155 \u2014 Good clinical practice<\/li>\n<\/ul>\n\n<\/div><\/div>\n<\/div>\n\n\n<div style=\"height:33px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h5 class=\"wp-block-heading\"><strong><strong>EN-IEC : Forfait pour les dispositifs m\u00e9dicaux<\/strong><\/strong><\/h5>\n\n\n<div class=\"gb-grid-wrapper gb-grid-wrapper-319e375a\">\n<div class=\"gb-grid-column gb-grid-column-aa89695f\"><div class=\"gb-container gb-container-aa89695f\">\n\n<ul class=\"wp-block-list\">\n<li class=\"has-medium-font-size\"><strong><strong><strong>Logiciels et utilisabilit\u00e9 des dispositifs m\u00e9dicaux<\/strong><\/strong><\/strong><\/li>\n\n\n\n<li>EN-IEC 62304 \u2014 Medical device software lifecycle processes<\/li>\n\n\n\n<li>EN-IEC 62366 Series \u2014 Usability engineering for medical devices\n<ul class=\"wp-block-list\">\n<li>Inclut EN-IEC 62366-1 et EN-IEC 62366-2<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-a2ca7de8\"><div class=\"gb-container gb-container-a2ca7de8\">\n\n<ul class=\"wp-block-list\">\n<li class=\"has-medium-font-size\"><strong><strong><strong><strong>\u00c9quipements \u00e9lectrom\u00e9dicaux<\/strong><\/strong><\/strong><\/strong><\/li>\n\n\n\n<li>EN-IEC 60601 Series \u2014 Safety and performance of medical electrical equipment\n<ul class=\"wp-block-list\">\n<li>Inclut EN-IEC 60601-1, EN-IEC 60601-1-2, EN-IEC 60601-1-6, EN-IEC 60601-1-8, et EN-IEC 60601-1-11<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n<\/div><\/div>\n<\/div>\n\n\n<div style=\"height:33px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<figure class=\"gb-block-image gb-block-image-484fdda3\"><img decoding=\"async\" width=\"1024\" height=\"576\" class=\"gb-image gb-image-484fdda3\" src=\"https:\/\/nimonik.com\/wp-content\/uploads\/Medical-Device_Customer-Reviews_Nimonik-1024x576.jpg\" alt=\"\" title=\"Medical Device_Customer Reviews_Nimonik\" srcset=\"https:\/\/nimonik.com\/wp-content\/uploads\/Medical-Device_Customer-Reviews_Nimonik-1024x576.jpg 1024w, https:\/\/nimonik.com\/wp-content\/uploads\/Medical-Device_Customer-Reviews_Nimonik-300x169.jpg 300w, https:\/\/nimonik.com\/wp-content\/uploads\/Medical-Device_Customer-Reviews_Nimonik-1536x864.jpg 1536w, https:\/\/nimonik.com\/wp-content\/uploads\/Medical-Device_Customer-Reviews_Nimonik.jpg 1920w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<div style=\"height:33px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h6 class=\"wp-block-heading has-text-align-center\">Contactez-nous pour en savoir plus sur nos forfaits de normes essentielles pour les dispositifs m\u00e9dicaux, ou pour cr\u00e9er un abonnement sur mesure comprenant des normes suppl\u00e9mentaires issues de l&rsquo;ISO, de l&rsquo;IEC, de l&rsquo;ASTM, de l&rsquo;AAMI et bien d&rsquo;autres encore !<\/h6>\n\n\n<div class=\"gb-container gb-container-6600940d\">\n\n<a class=\"gb-button gb-button-f95d96f5 gb-button-text smooth-scroll\" href=\"https:\/\/nimonik.com\/fr\/request-a-demo\/\">Planifier votre d\u00e9mo<\/a>\n\n<\/div>\n\n\n<div style=\"height:80px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<\/div><div class=\"gb-shapes\"><div class=\"gb-shape gb-shape-1\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 1200 360\" preserveAspectRatio=\"none\"><path d=\"M1200 360H0V0l1200 348z\"\/><\/svg><\/div><div class=\"gb-shape gb-shape-2\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 1200 360\" preserveAspectRatio=\"none\"><path d=\"M1200 360H0V0l1200 348z\"\/><\/svg><\/div><\/div><\/div>\n\n<div class=\"gb-container gb-container-fe8157a5\"><div class=\"gb-inside-container\">\n<div class=\"gb-container gb-container-d7372a3e\"><div class=\"gb-inside-container\">\n\n<h2 class=\"gb-headline gb-headline-7e8fbb4f gb-headline-text\"><strong><strong>T\u00e9moignages de nos pr\u00e9cieux clients<\/strong><\/strong><\/h2>\n\n\n<div class=\"gb-container gb-container-3705067c\">\n<div class=\"gb-container gb-container-876f4947\">\n<div class=\"gb-grid-wrapper gb-grid-wrapper-e1fb4fa2\">\n<div class=\"gb-grid-column gb-grid-column-59af273d\"><div class=\"gb-container gb-container-59af273d\">\n\n<p class=\"gb-headline gb-headline-79967a06\"><span class=\"gb-icon\"><svg aria-hidden=\"true\" role=\"img\" height=\"1em\" width=\"1em\" viewBox=\"0 0 576 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path fill=\"currentColor\" d=\"M576 240c0-23.63-12.95-44.04-32-55.12V32.01C544 23.26 537.02 0 512 0c-7.12 0-14.19 2.38-19.98 7.02l-85.03 68.03C364.28 109.19 310.66 128 256 128H64c-35.35 0-64 28.65-64 64v96c0 35.35 28.65 64 64 64h33.7c-1.39 10.48-2.18 21.14-2.18 32 0 39.77 9.26 77.35 25.56 110.94 5.19 10.69 16.52 17.06 28.4 17.06h74.28c26.05 0 41.69-29.84 25.9-50.56-16.4-21.52-26.15-48.36-26.15-77.44 0-11.11 1.62-21.79 4.41-32H256c54.66 0 108.28 18.81 150.98 52.95l85.03 68.03a32.023 32.023 0 0 0 19.98 7.02c24.92 0 32-22.78 32-32V295.13C563.05 284.04 576 263.63 576 240zm-96 141.42l-33.05-26.44C392.95 311.78 325.12 288 256 288v-96c69.12 0 136.95-23.78 190.95-66.98L480 98.58v282.84z\"><\/path><\/svg><\/span><span class=\"gb-headline-text\"><em><em>Je tiens \u00e0 vous remercier d&rsquo;\u00eatre si r\u00e9actifs \u00e0 mes demandes de documents. Vous \u00eates formidables et traitez vos clients comme je souhaiterais que tout le monde le fasse&#8230; et bien au-del\u00e0 de la plupart des d\u00e9partements de service client!<\/em><\/em><br><strong>\u2013 Ing\u00e9nieur chez une grande entreprise de dispositifs m\u00e9dicaux<\/strong><\/span><\/p>\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-0446e5f1\"><div class=\"gb-container gb-container-0446e5f1\">\n\n<p class=\"gb-headline gb-headline-b09ffd3a\"><span class=\"gb-icon\"><svg aria-hidden=\"true\" role=\"img\" height=\"1em\" width=\"1em\" viewBox=\"0 0 576 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path fill=\"currentColor\" d=\"M576 240c0-23.63-12.95-44.04-32-55.12V32.01C544 23.26 537.02 0 512 0c-7.12 0-14.19 2.38-19.98 7.02l-85.03 68.03C364.28 109.19 310.66 128 256 128H64c-35.35 0-64 28.65-64 64v96c0 35.35 28.65 64 64 64h33.7c-1.39 10.48-2.18 21.14-2.18 32 0 39.77 9.26 77.35 25.56 110.94 5.19 10.69 16.52 17.06 28.4 17.06h74.28c26.05 0 41.69-29.84 25.9-50.56-16.4-21.52-26.15-48.36-26.15-77.44 0-11.11 1.62-21.79 4.41-32H256c54.66 0 108.28 18.81 150.98 52.95l85.03 68.03a32.023 32.023 0 0 0 19.98 7.02c24.92 0 32-22.78 32-32V295.13C563.05 284.04 576 263.63 576 240zm-96 141.42l-33.05-26.44C392.95 311.78 325.12 288 256 288v-96c69.12 0 136.95-23.78 190.95-66.98L480 98.58v282.84z\"><\/path><\/svg><\/span><span class=\"gb-headline-text\"><em>Je ne peux pas commencer \u00e0 vous dire \u00e0 quel point Nimonik est informatif et utile..<\/em>.<br><strong>\u2013 Responsable technique chez une entreprise de dispositifs m\u00e9dicaux<\/strong><\/span><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n<div class=\"gb-container gb-container-7536175a\"><div class=\"gb-inside-container\">\n\n<div style=\"height:140px\" aria-hidden=\"true\" id=\"nimonik-pricing-plans\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"gb-container gb-container-a16455a1\"><div class=\"gb-inside-container\">\n\n<h2 class=\"wp-block-heading\"><strong><strong><strong>Gardez une longueur d&rsquo;avance sur les r\u00e9glementations mondiales gr\u00e2ce \u00e0 des mises \u00e0 jour en temps r\u00e9el<\/strong><\/strong><\/strong><\/h2>\n\n\n\n<p class=\"has-text-align-left\">Recevez des mises \u00e0 jour r\u00e9glementaires en temps r\u00e9el concernant les nouvelles r\u00e9glementations et les projets de r\u00e9glementation afin de garantir la conformit\u00e9 de votre entreprise sur plusieurs march\u00e9s ; Nimonik dispose de l&rsquo;une des bases de donn\u00e9es r\u00e9glementaires les plus compl\u00e8tes, avec plus de 600 000 documents provenant de 75 pays. Acc\u00e9dez aux derniers documents r\u00e9glementaires directement depuis la plateforme pour \u00e9liminer la charge li\u00e9e au suivi manuel, acc\u00e9l\u00e9rer les autorisations de mise sur le march\u00e9 et r\u00e9duire les risques de non-conformit\u00e9 associ\u00e9s \u00e0 des informations obsol\u00e8tes ou incoh\u00e9rentes.<\/p>\n\n\n\n<p>Acc\u00e9l\u00e9rez la prise de d\u00e9cision gr\u00e2ce \u00e0 des fonctionnalit\u00e9s bas\u00e9es sur l&rsquo;IA, notamment des r\u00e9sum\u00e9s g\u00e9n\u00e9r\u00e9s par l&rsquo;IA et les exigences d\u00e9taill\u00e9es des textes am\u00e9lior\u00e9s par l&rsquo;IA, pour comprendre rapidement les exigences essentielles sans avoir \u00e0 lire l&rsquo;int\u00e9gralit\u00e9 du document. Les analyses d&rsquo;applicabilit\u00e9 par l&rsquo;IA \u2014 permettant de d\u00e9terminer si une obligation s&rsquo;applique, pourrait s&rsquo;appliquer ou ne s&rsquo;applique pas \u00e0 un \u00e9tablissement donn\u00e9 \u2014 sont actuellement en phase de test et seront bient\u00f4t disponibles.&nbsp;<\/p>\n\n\n\n<p class=\"has-text-align-left\">Les \u00e9quipes peuvent \u00e9galement tirer parti d&rsquo;outils de workflow d&rsquo;origines pour extraire des exigences sp\u00e9cifiques et les transformer en \u00e9tapes op\u00e9rationnelles concr\u00e8tes. En reliant ces obligations directement aux \u00e9valuations des risques et aux mod\u00e8les d&rsquo;audit, Nimonik aide les entreprises de dispositifs m\u00e9dicaux \u00e0 se mettre en conformit\u00e9 tout en lib\u00e9rant leur personnel des t\u00e2ches de suivi des documents et de saisie des donn\u00e9es.<\/p>\n\n\n\n<div style=\"height:44px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><strong><strong>Dossiers r\u00e9glementaires essentiels pour les dispositifs m\u00e9dicaux<\/strong><\/strong><\/h2>\n\n\n\n<p class=\"has-text-align-left\">Nimonik propose des collections de veille r\u00e9glementaire tr\u00e8s abordables pour les principaux cadres r\u00e9glementaires applicables aux dispositifs m\u00e9dicaux. Les dossiers r\u00e9glementaires peuvent \u00eatre configur\u00e9s en fonction des juridictions dans lesquelles une organisation exerce ses activit\u00e9s, ce qui permet aux entreprises de se concentrer sur les exigences r\u00e9glementaires les plus pertinentes pour leurs march\u00e9s.<\/p>\n\n\n\n<p class=\"has-text-align-left\">Les forfaits r\u00e9glementaires essentiels pour les dispositifs m\u00e9dicaux sont disponibles pour l&rsquo;une des trois juridictions suivantes :&nbsp;<\/p>\n\n\n\n<h5 class=\"wp-block-heading\"><strong><strong>Cadre r\u00e9glementaire : Union europ\u00e9enne&nbsp;<\/strong><\/strong><\/h5>\n\n\n\n<ul class=\"wp-block-list\">\n<li>R\u00e8glement europ\u00e9en sur les dispositifs m\u00e9dicaux (MDR \u2013 R\u00e8glement (UE) 2017\/745)<\/li>\n\n\n\n<li>R\u00e8glement europ\u00e9en sur les dispositifs m\u00e9dicaux de diagnostic in vitro (IVDR \u2013 R\u00e8glement (UE) 2017\/746)<\/li>\n\n\n\n<li>Documents d&rsquo;orientation du MDCG accompagnant la mise en \u0153uvre du cadre r\u00e9glementaire europ\u00e9en<\/li>\n<\/ul>\n\n\n\n<h5 class=\"wp-block-heading\"><strong><strong>Cadre r\u00e9glementaire : \u00c9tats-Unis<\/strong><\/strong><\/h5>\n\n\n\n<ul class=\"wp-block-list\">\n<li>R\u00e9glementations de la FDA relatives aux dispositifs m\u00e9dicaux (21 CFR Parties 800\u2013898)<\/li>\n\n\n\n<li>Documents d&rsquo;orientation pertinents de la FDA traitant de sujets tels que la s\u00e9curit\u00e9 des dispositifs, l&rsquo;\u00e9valuation clinique et les obligations post-commercialisation<\/li>\n<\/ul>\n\n\n\n<h5 class=\"wp-block-heading\"><strong><strong>Cadre r\u00e9glementaire : Canada<\/strong><\/strong><\/h5>\n\n\n\n<ul class=\"wp-block-list\">\n<li>R\u00e8glement sur les instruments m\u00e9dicaux (SOR\/98-282) administr\u00e9 par Sant\u00e9 Canada\n<ul class=\"wp-block-list\">\n<li>Documents d&rsquo;orientation r\u00e9glementaires d&rsquo;accompagnement<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h5 class=\"wp-block-heading\"><strong>En prime : documents d&rsquo;orientation internationaux<\/strong><\/h5>\n\n\n\n<p>Chaque dossier par juridiction comprend \u00e9galement un ensemble de documents suppl\u00e9mentaires couvrant les documents d&rsquo;orientation r\u00e9glementaires internationaux.&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Documents d&rsquo;orientation de l&rsquo;IMDRF (Forum international des autorit\u00e9s de r\u00e9glementation des dispositifs m\u00e9dicaux), qui favorisent la convergence r\u00e9glementaire et les meilleures pratiques internationales en mati\u00e8re de r\u00e9glementation des dispositifs m\u00e9dicaux<\/li>\n\n\n\n<li>Anciens documents d&rsquo;orientation du GHTF qui continuent d&rsquo;influencer les approches r\u00e9glementaires mondiales<\/li>\n<\/ul>\n\n\n\n<p>Donnez \u00e0 votre \u00e9quipe les moyens de rester en conformit\u00e9 et de g\u00e9rer facilement les processus d&rsquo;autorisation complexes. En suivant les mises \u00e0 jour r\u00e9glementaires, en comprenant les exigences d&rsquo;entr\u00e9e sur le march\u00e9 et en attribuant des t\u00e2ches concr\u00e8tes, les entreprises du secteur des dispositifs m\u00e9dicaux peuvent acc\u00e9l\u00e9rer la mise sur le march\u00e9 et r\u00e9agir plus rapidement \u00e0 des exigences en constante \u00e9volution. Les clients peuvent \u00e0 tout moment ajouter des juridictions et des th\u00e8mes suppl\u00e9mentaires \u00e0 leur abonnement afin de r\u00e9pondre \u00e0 des exigences suppl\u00e9mentaires.&nbsp;<\/p>\n\n\n\n<p class=\"has-text-align-left\">Vous ne trouvez pas le contenu r\u00e9glementaire dont vous avez besoin ? Contactez-nous pour discuter des autres possibilit\u00e9s.<\/p>\n\n\n<div class=\"gb-container gb-container-cb3c44e1\">\n\n<a class=\"gb-button gb-button-3ed4c372 gb-button-text smooth-scroll\" href=\"#form\">Planifier votre d\u00e9mo<\/a>\n\n<\/div>\n<\/div><\/div>\n\n\n<div style=\"height:33px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<\/div><div class=\"gb-shapes\"><div class=\"gb-shape gb-shape-1\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 1200 360\" preserveAspectRatio=\"none\"><path d=\"M1200 360H0V0l1200 348z\"\/><\/svg><\/div><div class=\"gb-shape gb-shape-2\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 1200 360\" preserveAspectRatio=\"none\"><path d=\"M1200 360H0V0l1200 348z\"\/><\/svg><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>Principaux organismes de normalisation (SDOs) du secteur des dispositifs m\u00e9dicaux chez Nimonik Acc\u00e8s abordable aux normes Nimonik propose un ensemble de normes industrielles \u00e0 prix avantageux destin\u00e9 aux petites et moyennes entreprises du secteur des dispositifs m\u00e9dicaux qui souhaitent acc\u00e9der aux normes ISO et IEC essentielles \u00e0 ce secteur, ainsi qu&rsquo;aux outils et fonctionnalit\u00e9s de &#8230; <a title=\"Dispositifs m\u00e9dicaux\" class=\"read-more\" href=\"https:\/\/nimonik.com\/fr\/industries-2\/dispositifs-medicaux\/\" aria-label=\"En savoir plus sur Dispositifs m\u00e9dicaux\">Lire plus<\/a><\/p>\n","protected":false},"author":72,"featured_media":0,"parent":37545,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":{"0":"post-51616","1":"page","2":"type-page","3":"status-publish","5":"no-featured-image-padding"},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Industrie des Dispositifs M\u00e9dicaux: Votre Partenaire de Conformit\u00e9<\/title>\n<meta name=\"description\" content=\"Les solutions de conformit\u00e9 de Nimonik permettent de vous adapter aux r\u00e9glementations et maintenir la qualit\u00e9 et comp\u00e9titivit\u00e9 de vos produits.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/nimonik.com\/fr\/industries-2\/dispositifs-medicaux\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Industrie des Dispositifs M\u00e9dicaux: Votre Partenaire de Conformit\u00e9\" \/>\n<meta property=\"og:description\" content=\"Les solutions de conformit\u00e9 de Nimonik permettent de vous adapter aux r\u00e9glementations et maintenir la qualit\u00e9 et comp\u00e9titivit\u00e9 de vos produits.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/nimonik.com\/fr\/industries-2\/dispositifs-medicaux\/\" \/>\n<meta property=\"og:site_name\" content=\"Nimonik\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/NimonikInc\" \/>\n<meta property=\"article:modified_time\" content=\"2026-05-22T16:09:49+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/nimonik.com\/wp-content\/uploads\/Nimonik_Medical_Device_Subscription_Packages_Image-scaled.png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:site\" content=\"@Nimonik_Inc\" \/>\n<meta name=\"twitter:label1\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data1\" content=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" 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