{"id":82111,"date":"2026-07-16T11:11:33","date_gmt":"2026-07-16T09:11:33","guid":{"rendered":"https:\/\/www.teoresigroup.com\/?p=82111"},"modified":"2026-07-20T09:55:20","modified_gmt":"2026-07-20T07:55:20","slug":"iec-62304-and-iec-81001-5-1-a-new-integrated-approach-to-medical-software","status":"publish","type":"post","link":"https:\/\/www.teoresigroup.com\/de\/news\/iec-62304-and-iec-81001-5-1-a-new-integrated-approach-to-medical-software\/","title":{"rendered":"IEC 62304 and IEC 81001-5-1: a new integrated approach to medical software"},"content":{"rendered":"\n<div class=\"wp-block-columns row align-center row sezione\">\n<div class=\"wp-block-column column small-12 medium-10 large-8\">\n<p>Medical software development increasingly requires an approach that combines <strong>safety <\/strong>and <strong>cybersecurity <\/strong>throughout the entire product lifecycle. While<strong> IEC 62304<\/strong> is the reference standard for the medical software lifecycle, <strong>IEC 81001-5-1<\/strong> builds on this framework by introducing specific cybersecurity requirements for software development and maintenance.<\/p>\n\n\n\n<p>The article explains how the two standards complement each other. IEC 62304 focuses on software lifecycle processes and functional safety, whereas IEC 81001-5-1 introduces concepts such as Secure Development Lifecycle, Threat Modeling, vulnerability management, and security updates to strengthen software resilience in real-world environments.<\/p>\n\n\n\n<p>Together, the two standards redefine how medical software is designed, verified, and maintained, integrating both safety and security into a single risk management framework.<\/p>\n\n\n\n<p>Want to learn more about the new integrated model for medical software?<\/p>\n\n\n\n<p>Download <a href=\"https:\/\/www.linkedin.com\/in\/maria-santoro96\/\">Maria Santoro<\/a>&#8217;s full technical article or explore more insights in our MedTech Publications section.<\/p>\n\n\n        \n        <div id=\"block_65cb2f7ea3ddfb37b8524a827ab3a221\" class=\"file-attachment-repeater row sezione pt-0 align-center\">\n\n            <div class=\"column small-12\">\n\n                \n                     <a class=\"attachment flex align-middle p-3 mb-2 fs-p color-body\" href=\"https:\/\/www.teoresigroup.com\/wp-content\/uploads\/2026\/07\/the-new-integrated-model-of-medical-software-iec-62304-iec-81001-5-1.pdf\" target=\"_blank\" rel=\"nofollow noopener\" onclick=\"ga('send', 'event', 'Action-Link', 'Click', 'Download the PDF');\"><svg class=\"icon download width-8 mr-4 color-primary\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 576 512\"><path d=\"M528 288h-92.1l46.1-46.1c30.1-30.1 8.8-81.9-33.9-81.9h-64V48c0-26.5-21.5-48-48-48h-96c-26.5 0-48 21.5-48 48v112h-64c-42.6 0-64.2 51.7-33.9 81.9l46.1 46.1H48c-26.5 0-48 21.5-48 48v128c0 26.5 21.5 48 48 48h480c26.5 0 48-21.5 48-48V336c0-26.5-21.5-48-48-48zm-400-80h112V48h96v160h112L288 368 128 208zm400 256H48V336h140.1l65.9 65.9c18.8 18.8 49.1 18.7 67.9 0l65.9-65.9H528v128zm-88-64c0-13.3 10.7-24 24-24s24 10.7 24 24-10.7 24-24 24-24-10.7-24-24z\"\/><\/svg>Download the PDF<\/a>\n                \n            <\/div>\n\n        <\/div>\n\n    \n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p class=\"excerpt\">Medical software development increasingly requires an approach that combines safety and cybersecurity throughout the entire product lifecycle. While IEC 62304 is the reference standard for the medical software lifecycle, IEC 81001-5-1 builds on this framework by introducing specific cybersecurity requirements for software development and maintenance. The article explains how the two standards complement each other. IEC 62304 focuses on software&#8230;<\/p>\n","protected":false},"author":18,"featured_media":83509,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[568,764],"tags":[730],"class_list":["post-82111","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medtech-3","category-medtech-de","tag-medtech"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>IEC 62304 and IEC 81001-5-1: a new integrated approach to medical software - Teoresi Group<\/title>\n<meta name=\"description\" content=\"Discover all you need to know about IEC 62304 and IEC 81001-5-1: a new integrated approach to medical software on Teoresi Group - Teoresi Group is high profile engineering. It offers an innovative approach in close synergy with the Research and Development departments of the main industrial players.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.teoresigroup.com\/de\/news\/iec-62304-and-iec-81001-5-1-a-new-integrated-approach-to-medical-software\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"IEC 62304 and IEC 81001-5-1: a new integrated approach to medical software - Teoresi Group\" \/>\n<meta property=\"og:description\" content=\"Discover all you need to know about IEC 62304 and IEC 81001-5-1: a new integrated approach to medical software on Teoresi Group - Teoresi Group is high profile engineering. It offers an innovative approach in close synergy with the Research and Development departments of the main industrial players.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.teoresigroup.com\/de\/news\/iec-62304-and-iec-81001-5-1-a-new-integrated-approach-to-medical-software\/\" \/>\n<meta property=\"og:site_name\" content=\"Teoresi Group\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/pages\/Gruppo-Teoresi\/118393464917205\" \/>\n<meta property=\"article:published_time\" content=\"2026-07-16T09:11:33+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-20T07:55:20+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.teoresigroup.com\/wp-content\/uploads\/2026\/07\/iec-62304-and-iec-81001-5-1-the-new-integrated-model-for-medical-software-1.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1009\" \/>\n\t<meta property=\"og:image:height\" content=\"757\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"ExportImportUser\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Verfasst von\" \/>\n\t<meta name=\"twitter:data1\" content=\"ExportImportUser\" \/>\n\t<meta name=\"twitter:label2\" content=\"Gesch\u00e4tzte Lesezeit\" \/>\n\t<meta name=\"twitter:data2\" content=\"1\u00a0Minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.teoresigroup.com\\\/de\\\/news\\\/iec-62304-and-iec-81001-5-1-a-new-integrated-approach-to-medical-software\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.teoresigroup.com\\\/de\\\/news\\\/iec-62304-and-iec-81001-5-1-a-new-integrated-approach-to-medical-software\\\/\"},\"author\":{\"name\":\"ExportImportUser\",\"@id\":\"https:\\\/\\\/www.teoresigroup.com\\\/it\\\/#\\\/schema\\\/person\\\/ba9d5f6eb364ab3aef7f57292e15d827\"},\"headline\":\"IEC 62304 and IEC 81001-5-1: a new integrated approach to medical software\",\"datePublished\":\"2026-07-16T09:11:33+00:00\",\"dateModified\":\"2026-07-20T07:55:20+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.teoresigroup.com\\\/de\\\/news\\\/iec-62304-and-iec-81001-5-1-a-new-integrated-approach-to-medical-software\\\/\"},\"wordCount\":153,\"publisher\":{\"@id\":\"https:\\\/\\\/www.teoresigroup.com\\\/it\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/www.teoresigroup.com\\\/de\\\/news\\\/iec-62304-and-iec-81001-5-1-a-new-integrated-approach-to-medical-software\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.teoresigroup.com\\\/wp-content\\\/uploads\\\/2026\\\/07\\\/iec-62304-and-iec-81001-5-1-the-new-integrated-model-for-medical-software-1.png\",\"keywords\":[\"medtech\"],\"articleSection\":[\"MedTech\",\"MedTech\"],\"inLanguage\":\"de\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.teoresigroup.com\\\/de\\\/news\\\/iec-62304-and-iec-81001-5-1-a-new-integrated-approach-to-medical-software\\\/\",\"url\":\"https:\\\/\\\/www.teoresigroup.com\\\/de\\\/news\\\/iec-62304-and-iec-81001-5-1-a-new-integrated-approach-to-medical-software\\\/\",\"name\":\"IEC 62304 and IEC 81001-5-1: a new integrated approach to medical software - Teoresi Group\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.teoresigroup.com\\\/it\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.teoresigroup.com\\\/de\\\/news\\\/iec-62304-and-iec-81001-5-1-a-new-integrated-approach-to-medical-software\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.teoresigroup.com\\\/de\\\/news\\\/iec-62304-and-iec-81001-5-1-a-new-integrated-approach-to-medical-software\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.teoresigroup.com\\\/wp-content\\\/uploads\\\/2026\\\/07\\\/iec-62304-and-iec-81001-5-1-the-new-integrated-model-for-medical-software-1.png\",\"datePublished\":\"2026-07-16T09:11:33+00:00\",\"dateModified\":\"2026-07-20T07:55:20+00:00\",\"description\":\"Discover all you need to know about IEC 62304 and IEC 81001-5-1: a new integrated approach to medical software on Teoresi Group - Teoresi Group is high profile engineering. 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