{"id":444,"date":"2024-03-11T20:54:47","date_gmt":"2024-03-11T20:54:47","guid":{"rendered":"https:\/\/kobalt-software.eu\/?page_id=444"},"modified":"2025-06-25T12:04:08","modified_gmt":"2025-06-25T12:04:08","slug":"solution-english","status":"publish","type":"page","link":"https:\/\/kobalt-software.eu\/?page_id=444&lang=en","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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Regulatory analysis and strategy<\/h2>\n\n\n\n

We help you with strategic analysis and advice (medical device classification, intended use, market access, ressources, …).<\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n

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Gap Analysis and compliance<\/h2>\n\n\n\n

Regulatory and technical inventory to identify deviations and bring you back into compliance.<\/p>\n<\/div>\n\n\n\n

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Quality Management System<\/h2>\n\n\n\n

Evaluation of internal practices and we help you building procedures with your teams.<\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n

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Technical File<\/h2>\n\n\n\n

We help and prepare your teams to build and maintain your technical file:
Compliance with IEC 62304 and IEC 82304 for your software systems
Risk management following ISO 14971, including cybersecurity risks and specific AI-related risks
Usability according to IEC 62366
Requirements of the medical regulation (MDR), electro-medical standards (60601 family), biocompatibility, and all specific and particular standards<\/p>\n<\/div>\n\n\n\n

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Clinical approach<\/h2>\n\n\n\n

Clinical evaluation plan and report, and Post market surveillance.<\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n

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Standards analysis and monitoring<\/h2>\n\n\n\n

Standards requirements to operational requirements translation, in numeric format.<\/p>\n<\/div>\n\n\n\n

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Software project management and development<\/h2>\n\n\n\n

Especially with IEC 62304 compliance.<\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n

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Training and specific support<\/h2>\n\n\n\n

For all your teams (management, quality, regulatory or technical).<\/p>\n<\/div>\n\n\n\n

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Fixed-price contract or by delegation<\/h2>\n\n\n\n

We adapt your way !<\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n

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Let’s work together<\/h2>\n\n\n\n
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CONTACT US<\/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-444","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=444&lang=en\" \/>\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=444&lang=en\" \/>\n<meta property=\"og:site_name\" content=\"Kobalt Software\" \/>\n<meta property=\"article:modified_time\" content=\"2025-06-25T12:04:08+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=\"3 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=444&lang=en\",\"url\":\"https:\\\/\\\/kobalt-software.eu\\\/?page_id=444&lang=en\",\"name\":\"Solutions - Kobalt Software\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/kobalt-software.eu\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/kobalt-software.eu\\\/?page_id=444&lang=en#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/kobalt-software.eu\\\/?page_id=444&lang=en#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/kobalt-software.eu\\\/wp-content\\\/uploads\\\/2024\\\/03\\\/iStock-1202962796-10-edited.png\",\"datePublished\":\"2024-03-11T20:54:47+00:00\",\"dateModified\":\"2025-06-25T12:04:08+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=444&lang=en#breadcrumb\"},\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/kobalt-software.eu\\\/?page_id=444&lang=en\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/kobalt-software.eu\\\/?page_id=444&lang=en#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=444&lang=en#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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