{"id":116409,"date":"2026-05-18T09:15:12","date_gmt":"2026-05-18T07:15:12","guid":{"rendered":"https:\/\/novak-m.com\/?p=116409"},"modified":"2026-05-18T09:15:12","modified_gmt":"2026-05-18T07:15:12","slug":"iso-13485-obtenu","status":"publish","type":"post","link":"https:\/\/novak-m.com\/fr\/iso-13485-obtenu\/","title":{"rendered":"ISO 13485 : la norme qui soutient nos produits"},"content":{"rendered":"<h2>Que signifie ISO 13485 ?<\/h2>\n<p>Jusqu\u2019\u00e0 pr\u00e9sent, nous travaillions conform\u00e9ment \u00e0 la norme<strong> ISO 9001<\/strong>, qui confirme l\u2019existence d\u2019un syst\u00e8me de management de la qualit\u00e9 bien structur\u00e9. Avec ISO 13485, nous franchissons une \u00e9tape suppl\u00e9mentaire. ISO 13485 est sp\u00e9cifiquement adapt\u00e9e aux exigences de l\u2019industrie m\u00e9dicale, o\u00f9 la s\u00e9curit\u00e9, la tra\u00e7abilit\u00e9, la ma\u00eetrise des processus et le respect constant des exigences r\u00e9glementaires sont essentiels.<\/p>\n<p>En termes simples : ISO 13485 est notre engagement \u00e0 ne faire aucun compromis sur la qualit\u00e9 et la s\u00e9curit\u00e9 des dispositifs m\u00e9dicaux.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-116387\" src=\"https:\/\/novak-m.com\/wp-content\/uploads\/2026\/05\/ISO-13485_2016.webp\" alt=\"\" width=\"750\" height=\"483\" srcset=\"https:\/\/novak-m.com\/wp-content\/uploads\/2026\/05\/ISO-13485_2016.webp 750w, https:\/\/novak-m.com\/wp-content\/uploads\/2026\/05\/ISO-13485_2016-300x193.webp 300w, https:\/\/novak-m.com\/wp-content\/uploads\/2026\/05\/ISO-13485_2016-186x120.webp 186w, https:\/\/novak-m.com\/wp-content\/uploads\/2026\/05\/ISO-13485_2016-600x386.webp 600w\" sizes=\"auto, (max-width: 750px) 100vw, 750px\" \/><\/p>\n<h2>Qu\u2019est-ce que cela signifie pour les utilisateurs ?<\/h2>\n<p>Pour les utilisateurs finaux, cela repr\u00e9sente bien plus qu\u2019une conformit\u00e9 formelle. C\u2019est une garantie suppl\u00e9mentaire que nos processus de conception, de production, de contr\u00f4le et de documentation r\u00e9pondent aux exigences \u00e9lev\u00e9es applicables au secteur des \u00e9quipements m\u00e9dicaux. La certification confirme que nous ma\u00eetrisons les risques de mani\u00e8re syst\u00e9matique, assurons la tra\u00e7abilit\u00e9 des mat\u00e9riaux et des processus, et travaillons continuellement \u00e0 l\u2019am\u00e9lioration de nos pratiques.<\/p>\n<div style='text-align:center;' class='ow_post_button'><a target='_self' href='https:\/\/novak-m.com\/fr\/'>D\u00e9couvrez nos produits<\/a><\/div>\n<h2>Conformit\u00e9 au MDR<\/h2>\n<p>Nos produits sont \u00e9galement conformes au r\u00e8glement europ\u00e9en relatif aux dispositifs m\u00e9dicaux (MDR). Associ\u00e9e \u00e0 ISO 13485, cette conformit\u00e9 signifie que nous ne suivons pas seulement les bonnes pratiques, mais que nous r\u00e9pondons \u00e9galement aux derni\u00e8res <a href=\"https:\/\/novak-m.com\/fr\/tables-d-examen-normes\/\"><strong>exigences l\u00e9gales<\/strong><\/a> du march\u00e9 europ\u00e9en. Pour les utilisateurs, c\u2019est une garantie suppl\u00e9mentaire qu\u2019ils utilisent des \u00e9quipements de qualit\u00e9 et fiables.<\/p>\n<h2>Une \u00e9tape en avant<\/h2>\n<p>Nous sommes fiers d\u2019avoir confirm\u00e9, gr\u00e2ce \u00e0 la certification ISO 13485, notre engagement envers la qualit\u00e9, la s\u00e9curit\u00e9 et la fiabilit\u00e9. Notre objectif reste le m\u00eame : fournir aux utilisateurs \u2014 personnel m\u00e9dical et patients \u2014 des produits et des solutions auxquels ils peuvent faire confiance.<\/p>\n<div style='text-align:center;' class='ow_post_button'><a target='_self' href='https:\/\/novak-m.com\/fr\/contact\/'>Contactez-nous<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Nous avons obtenu avec succ\u00e8s la certification ISO 13485, une norme internationalement reconnue relative aux syst\u00e8mes de management de la qualit\u00e9 pour les organisations op\u00e9rant dans le domaine des dispositifs m\u00e9dicaux et des \u00e9quipements m\u00e9dicaux.<\/p>\n","protected":false},"author":5,"featured_media":116383,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[310],"tags":[],"class_list":["post-116409","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualites"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>We obtained ISO 13485 \u2502 Novak M<\/title>\n<meta name=\"description\" content=\"ISO 13485 is our commitment to making no compromises when it comes to the quality and safety of medical devices.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/novak-m.com\/fr\/iso-13485-obtenu\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta 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