{"id":431,"date":"2024-03-11T20:47:06","date_gmt":"2024-03-11T20:47:06","guid":{"rendered":"https:\/\/kobalt-software.eu\/?page_id=431"},"modified":"2025-06-25T12:03:35","modified_gmt":"2025-06-25T12:03:35","slug":"solution-2","status":"publish","type":"page","link":"https:\/\/kobalt-software.eu\/?page_id=431","title":{"rendered":"Solutions"},"content":{"rendered":"\n
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Solutions<\/h2>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n
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Strat\u00e9gie et \u00e9tude r\u00e9glementaires<\/h2>\n\n\n\n

Nous vous aidons \u00e0 d\u00e9finir la meilleure strat\u00e9gie r\u00e9glementaire pour vous faire gagner du temps et optimiser vos march\u00e9s \u00e0 l’international.<\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n

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Gap Analysis et remise en conformit\u00e9<\/h2>\n\n\n\n

Nous r\u00e9alisons un \u00e9tat des lieux r\u00e9glementaire et vous aidons \u00e0 la remise en conformit\u00e9 de vos dossiers: suite \u00e0 des non-conformit\u00e9s, \u00e0 des \u00e9volutions de votre produit ou \u00e0 des changements r\u00e9glementaires.<\/p>\n<\/div>\n\n\n\n

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Mise en place du syst\u00e8me de management de la qualit\u00e9<\/h2>\n\n\n\n

D\u00e9finition et mise en place des proc\u00e9dures avec vos \u00e9quipes.<\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n

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Dossier Technique<\/h2>\n\n\n\n

R\u00e9alisation du dossier technique en coordination avec vos \u00e9quipes:
Conformit\u00e9 \u00e0 l’IEC 62304 et l’IEC 82304 pour vos syst\u00e8mes logiciels
Gestion des risques suivant l’ISO 14971 incluant les risques li\u00e9s \u00e0 la cybers\u00e9curit\u00e9 et les risques sp\u00e9cifiques IA
Aptitude \u00e0 l’utilisation suivant l’IEC 62366
Exigences du r\u00e8glement, des normes \u00e9lectro m\u00e9dicales (famille 60601), biocompatibilit\u00e9 et toutes normes sp\u00e9cifiques et particuli\u00e8res<\/p>\n<\/div>\n\n\n\n

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Approche clinique<\/h2>\n\n\n\n

R\u00e9alisation du plan, du rapport de l’\u00e9valuation clinique et la mise en place du suivi post-market.<\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n

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Veille et analyse normative<\/h2>\n\n\n\n

Veille r\u00e9glementaire et normative.
Analyse et traduction des exigences normatives en \u00e9l\u00e9ments op\u00e9rationnels (exigences techniques, risques, tests, proc\u00e9dures) sous forme num\u00e9rique.<\/p>\n<\/div>\n\n\n\n

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Gestion et d\u00e9veloppement de projets logiciels<\/h2>\n\n\n\n

Pilotage et r\u00e9alisation de vos logiciels suivant l’\u00e9tat de l’art de l’IEC 62304 et de l’IEC 82304, des exigences de s\u00e9curit\u00e9 informatique et des exigences technologiques (IA Act).<\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n

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Formation et accompagnement sp\u00e9cifique<\/h2>\n\n\n\n

Pour vos \u00e9quipes (direction, qualit\u00e9 ou technique), de la sensibilisation aux normes m\u00e9dicales jusqu’aux sujets particuliers.<\/p>\n<\/div>\n\n\n\n

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Mode projet ou au temps pass\u00e9<\/h2>\n\n\n\n

Nous nous adaptons \u00e0 vos contraintes !<\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n

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Ne perdez plus de temps<\/h2>\n\n\n\n
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CONTACTEZ NOUS<\/a><\/div>\n<\/div>\n\n\n\n
<\/div>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"neve_meta_sidebar":"","neve_meta_container":"","neve_meta_enable_content_width":"on","neve_meta_content_width":100,"neve_meta_title_alignment":"","neve_meta_author_avatar":"","neve_post_elements_order":"","neve_meta_disable_header":"","neve_meta_disable_footer":"","neve_meta_disable_title":"on","_themeisle_gutenberg_block_has_review":false,"footnotes":""},"class_list":["post-431","page","type-page","status-publish","hentry"],"yoast_head":"\nSolutions - Kobalt Software<\/title>\n<meta name=\"description\" content=\"Obtenir le marquage CE pour les fabricants de dispositifs m\u00e9dicaux qu'ils soient \u00e9lectro m\u00e9dical, logiciel ou autre, suivant le RDM (MDR)\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/kobalt-software.eu\/?page_id=431\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Solutions - Kobalt Software\" \/>\n<meta property=\"og:description\" content=\"Obtenir le marquage CE pour les fabricants de dispositifs m\u00e9dicaux qu'ils soient \u00e9lectro m\u00e9dical, logiciel ou autre, suivant le RDM (MDR)\" \/>\n<meta property=\"og:url\" content=\"https:\/\/kobalt-software.eu\/?page_id=431\" \/>\n<meta property=\"og:site_name\" content=\"Kobalt Software\" \/>\n<meta property=\"article:modified_time\" content=\"2025-06-25T12:03:35+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/kobalt-software.eu\/wp-content\/uploads\/2024\/03\/iStock-1202962796-10-edited.png\" \/>\n\t<meta property=\"og:image:width\" content=\"118\" \/>\n\t<meta property=\"og:image:height\" content=\"110\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data1\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/kobalt-software.eu\\\/?page_id=431\",\"url\":\"https:\\\/\\\/kobalt-software.eu\\\/?page_id=431\",\"name\":\"Solutions - Kobalt Software\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/kobalt-software.eu\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/kobalt-software.eu\\\/?page_id=431#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/kobalt-software.eu\\\/?page_id=431#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/kobalt-software.eu\\\/wp-content\\\/uploads\\\/2024\\\/03\\\/iStock-1202962796-10-edited.png\",\"datePublished\":\"2024-03-11T20:47:06+00:00\",\"dateModified\":\"2025-06-25T12:03:35+00:00\",\"description\":\"Obtenir le marquage CE pour les fabricants de dispositifs m\u00e9dicaux qu'ils soient \u00e9lectro m\u00e9dical, logiciel ou autre, suivant le RDM (MDR)\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/kobalt-software.eu\\\/?page_id=431#breadcrumb\"},\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/kobalt-software.eu\\\/?page_id=431\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/kobalt-software.eu\\\/?page_id=431#primaryimage\",\"url\":\"https:\\\/\\\/kobalt-software.eu\\\/wp-content\\\/uploads\\\/2024\\\/03\\\/iStock-1202962796-10-edited.png\",\"contentUrl\":\"https:\\\/\\\/kobalt-software.eu\\\/wp-content\\\/uploads\\\/2024\\\/03\\\/iStock-1202962796-10-edited.png\",\"width\":118,\"height\":110},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/kobalt-software.eu\\\/?page_id=431#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Accueil\",\"item\":\"https:\\\/\\\/kobalt-software.eu\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Solutions\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/kobalt-software.eu\\\/#website\",\"url\":\"https:\\\/\\\/kobalt-software.eu\\\/\",\"name\":\"Kobalt Software\",\"description\":\"Vos normes. 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