{"id":2416,"date":"2023-07-12T21:04:41","date_gmt":"2023-07-12T20:04:41","guid":{"rendered":"http:\/\/bioscom.onpressidium.com\/qualite-et-reglementation\/"},"modified":"2025-08-20T09:52:35","modified_gmt":"2025-08-20T08:52:35","slug":"qualite-et-reglementation","status":"publish","type":"page","link":"https:\/\/bioserenity.com\/fr\/qualite-et-reglementation\/","title":{"rendered":"Qualit\u00e9 et r\u00e9glementation"},"content":{"rendered":"\t\t
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Qualit\u00e9 et r\u00e9glementation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Dispositifs certifi\u00e9s en Europe<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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BioSerenity est un fabricant de dispositifs m\u00e9dicaux et op\u00e8re dans un cadre normatif et r\u00e9glementaire strict qui guide de mani\u00e8re \u00e9thique la commercialisation de nos dispositifs.<\/span><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Standard<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Une norme est une sp\u00e9cification technique, \u00e9labor\u00e9e par un consensus de professionnels et dont l’application est v\u00e9rifi\u00e9e par… Il atteste de la conformit\u00e9 d’un produit\/service\/processus\/syst\u00e8me \u00e0 un ensemble d’exigences. Les principales normes applicables aux dispositifs m\u00e9dicaux et en particulier aux dispositifs m\u00e9dicaux BioSerenity sont les suivantes (liste non exhaustive) :<\/span><\/p>\n

– <\/span><\/span>EN ISO 13485 : 2016 – Dispositifs m\u00e9dicaux – Syst\u00e8mes de management de la qualit\u00e9 – Exigences \u00e0 des fins r\u00e9glementaires <\/span><\/span><\/p>\n

– <\/span><\/span>EN ISO 14971 : 2019 – Dispositifs m\u00e9dicaux – Application de la gestion des risques aux dispositifs m\u00e9dicaux<\/span><\/p>\n

– <\/span><\/span>EN 60601-1 : 2006 – Appareils \u00e9lectrom\u00e9dicaux – Partie 1 : Exigences g\u00e9n\u00e9rales pour la s\u00e9curit\u00e9 de base et les <\/span>performances essentielles<\/span><\/p>\n

– <\/span><\/span>EN 62304 : 2006 – Logiciels pour dispositifs m\u00e9dicaux – Processus du cycle de vie du logiciel<\/span><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Conformit\u00e9 r\u00e9glementaire<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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La conformit\u00e9 r\u00e9glementaire, au-del\u00e0 du processus de certification, est l’adh\u00e9sion \u00e0 un ensemble de dispositions l\u00e9gislatives et r\u00e9glementaires ainsi qu’\u00e0 des normes et bonnes pratiques, afin de s’adapter \u00e0 toutes les exigences applicables \u00e0 un secteur (qualit\u00e9, mat\u00e9riovigilance, traitement des donn\u00e9es de sant\u00e9). Gr\u00e2ce \u00e0 son syst\u00e8me de gestion de la qualit\u00e9 et \u00e0 son service de conformit\u00e9, BioSerenity veille au respect de ces exigences en mati\u00e8re de qualit\u00e9, de performance et de s\u00e9curit\u00e9 de ses produits et services.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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MDSAP<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Le MDSAP (Medical Device Single Audit Program) est un programme international qui \u00e9value le syst\u00e8me de gestion de la qualit\u00e9 des fabricants de dispositifs m\u00e9dicaux dans les cinq territoires suivants : \u00c9tats-Unis, Canada, Br\u00e9sil, Australie et Japon. Ce programme r\u00e9cent permet de certifier, en un seul audit, le syst\u00e8me de gestion de la qualit\u00e9 d’une entreprise ayant cinq juridictions, en combinant les dispositions de la norme ISO 13485 : 2016 avec les exigences sp\u00e9cifiques des cinq pays suivants :<\/span><\/p>\n

– <\/span><\/span>Juridictions am\u00e9ricaines (21 CFR Part 820)<\/span><\/p>\n

– <\/span><\/span>Juridictions canadiennes (DORS 98-282)<\/span><\/p>\n

– <\/span><\/span>Juridictions br\u00e9siliennes (RDC 16\/2013)<\/span><\/p>\n

– <\/span><\/span>Juridictions japonaises (MHLW<\/span> MO169)<\/span><\/p>\n

– <\/span><\/span>Juridictions australiennes (Australian Therapeutic Goods Medical Devices Regulations 2002)<\/span><\/p>\n

BioSerenity a obtenu les certificats MDSAP depuis juin 2018. Le certificat MDSAP vise \u00e0 optimiser et \u00e0 acc\u00e9l\u00e9rer l’enregistrement des produits de Bioserenity dans deux pays (Canada, USA).<\/span><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tCertificat MDSAP<\/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
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Utilisation pr\u00e9vue de Neuronaute<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Le Neuronaute est un dispositif m\u00e9dical, compos\u00e9 d’un v\u00eatement et d’une application, qui enregistre des signaux \u00e9lectrophysiologiques \u00e0 des fins d’\u00e9lectroenc\u00e9phalographie.<\/p>\n\n

Le Neuronaute doit \u00eatre utilis\u00e9 par un professionnel de sant\u00e9 qualifi\u00e9.<\/p>\n\n

Le Neuronaute ne fait qu’acqu\u00e9rir et afficher des signaux physiologiques. Aucune revendication ne peut \u00eatre faite quant \u00e0 l’analyse des signaux acquis en termes d’exactitude, de pr\u00e9cision et de fiabilit\u00e9.<\/p>\n\n

Le Neuronaute est un dispositif m\u00e9dical de classe II selon le r\u00e8glement de classification de la FDA. Le Neuronaute ne fournit pas de diagnostic m\u00e9dical.<\/p>\n\n

Fabriqu\u00e9 et distribu\u00e9 par BioSerenity\n<\/p>

    \n \t
  • Neuronaute (K202334)<\/li>\n \t
  • Neuronaute avec IceCap 2 et 2 Small (K223644)<\/li>\n \t
  • Neuronaute Plus (K231366)<\/li>\n<\/ul>\n\n

    L’op\u00e9rateur doit toujours se r\u00e9f\u00e9rer au mode d’emploi avant d’utiliser le dispositif m\u00e9dical et doit lire attentivement toutes les instructions pour s’assurer de sa bonne utilisation.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

    Qualit\u00e9 et r\u00e9glementation Dispositifs certifi\u00e9s en Europe BioSerenity est un fabricant de dispositifs m\u00e9dicaux et op\u00e8re dans un cadre normatif et r\u00e9glementaire strict qui guide de mani\u00e8re \u00e9thique la commercialisation de nos dispositifs. Standard Une norme est une sp\u00e9cification technique, \u00e9labor\u00e9e par un consensus de professionnels et dont l’application est v\u00e9rifi\u00e9e par… Il atteste de […]<\/p>\n","protected":false},"author":16,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-2416","page","type-page","status-publish","hentry"],"blocksy_meta":[],"yoast_head":"\nQualit\u00e9 et r\u00e9glementation - BioSerenity<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/bioserenity.com\/fr\/qualite-et-reglementation\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Qualit\u00e9 et r\u00e9glementation\" \/>\n<meta property=\"og:description\" content=\"Qualit\u00e9 et r\u00e9glementation Dispositifs certifi\u00e9s en Europe BioSerenity est un fabricant de dispositifs m\u00e9dicaux et op\u00e8re dans un cadre normatif et r\u00e9glementaire strict qui guide de mani\u00e8re \u00e9thique la commercialisation de nos dispositifs. 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