{"id":85407,"date":"2026-10-29T12:22:51","date_gmt":"2026-10-29T11:22:51","guid":{"rendered":"https:\/\/www.teoresigroup.com\/?p=85407"},"modified":"2026-10-29T12:29:07","modified_gmt":"2026-10-29T11:29:07","slug":"medical-device-functional-safety-connecting-mdr-and-the-machinery-regulation","status":"publish","type":"post","link":"https:\/\/www.teoresigroup.com\/de\/news\/medical-device-functional-safety-connecting-mdr-and-the-machinery-regulation\/","title":{"rendered":"Medical device functional safety: connecting MDR and the Machinery Regulation\u00a0"},"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 device functional safety plays a central role when motors, sensors and software control movement or other potentially hazardous functions. <strong>How can these aspects be integrated into device design and risk management?\u00a0<\/strong><\/p>\n\n\n\n<p>The technical article <em><strong>\u201cMedical Devices and Machinery Regulation: The Challenge of Functional Safety\u201d<\/strong><\/em>, by <strong><a href=\"https:\/\/www.linkedin.com\/in\/maria-santoro96\/\">Maria Santoro<\/a>, Specialist Engineer of <a href=\"https:\/\/www.teoresigroup.com\/de\/company\/medtech\/\">Teoresi MedTech<\/a>,<\/strong> explores the relationship between the <strong>Medical Device Regulation<\/strong> (MDR) and <strong>European machinery legislation<\/strong>. Using examples ranging from surgical robotics to extracorporeal blood treatment systems, it discusses how to design and validate safety functions by considering the interaction between hardware, firmware and actuators.\u00a0<\/p>\n\n\n\n<p>The article also examines how standards including <strong>ISO 14971, ISO 13849-1 <\/strong>and <strong>IEC 62061 <\/strong>can support an integrated approach, offering useful insights for teams developing automated medical devices.\u00a0<\/p>\n\n\n\n<p>Read and download the paper to explore the role of functional safety in medical device design.<\/p>\n\n\n        \n        <div id=\"block_d023cfba8e1a4e94c4746eea3c7105fb\" 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\/10\/medical-devices-and-machinery-regulation-the-challenge-of-functional-safety-1.pdf\" target=\"_blank\" rel=\"nofollow noopener\" onclick=\"ga('send', 'event', 'Action-Link', 'Click', 'Download the full article here');\"><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 full article here<\/a>\n                \n            <\/div>\n\n        <\/div>\n\n    \n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p class=\"excerpt\">Medical device functional safety plays a central role when motors, sensors and software control movement or other potentially hazardous functions. How can these aspects be integrated into device design and risk management?\u00a0 The technical article \u201cMedical Devices and Machinery Regulation: The Challenge of Functional Safety\u201d, by Maria Santoro, Specialist Engineer of Teoresi MedTech, explores the relationship between the Medical Device&#8230;<\/p>\n","protected":false},"author":16,"featured_media":85402,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12,568],"tags":[828,877],"class_list":["post-85407","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-corporate","category-medtech-3","tag-medtech","tag-medtech-2"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.7 (Yoast SEO v28.7) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Medical device functional safety: connecting MDR and the Machinery Regulation\u00a0 - Teoresi Group<\/title>\n<meta name=\"description\" content=\"Discover all you need to know about Medical device functional safety: connecting MDR and the Machinery Regulation\u00a0 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\/medical-device-functional-safety-connecting-mdr-and-the-machinery-regulation\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical device functional safety: connecting MDR and the Machinery Regulation\u00a0\" \/>\n<meta property=\"og:description\" content=\"Discover all you need to know about Medical device functional safety: connecting MDR and the Machinery Regulation\u00a0 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\/medical-device-functional-safety-connecting-mdr-and-the-machinery-regulation\/\" \/>\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=\"2026-10-29T11:22:51+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-10-29T11:29:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.teoresigroup.com\/wp-content\/uploads\/2026\/10\/medical-device-functional-safety-connecting-mdr-and-the-machinery-regulation.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=\"Elisabetta Molli\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Verfasst von\" \/>\n\t<meta name=\"twitter:data1\" content=\"Elisabetta Molli\" \/>\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\\\/medical-device-functional-safety-connecting-mdr-and-the-machinery-regulation\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.teoresigroup.com\\\/de\\\/news\\\/medical-device-functional-safety-connecting-mdr-and-the-machinery-regulation\\\/\"},\"author\":{\"name\":\"Elisabetta Molli\",\"@id\":\"https:\\\/\\\/www.teoresigroup.com\\\/it\\\/#\\\/schema\\\/person\\\/3667db0b655576f01f3615051eb6a928\"},\"headline\":\"Medical device functional safety: connecting MDR and the Machinery Regulation\u00a0\",\"datePublished\":\"2026-10-29T11:22:51+00:00\",\"dateModified\":\"2026-10-29T11:29:07+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.teoresigroup.com\\\/de\\\/news\\\/medical-device-functional-safety-connecting-mdr-and-the-machinery-regulation\\\/\"},\"wordCount\":147,\"publisher\":{\"@id\":\"https:\\\/\\\/www.teoresigroup.com\\\/it\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/www.teoresigroup.com\\\/de\\\/news\\\/medical-device-functional-safety-connecting-mdr-and-the-machinery-regulation\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.teoresigroup.com\\\/wp-content\\\/uploads\\\/2026\\\/10\\\/medical-device-functional-safety-connecting-mdr-and-the-machinery-regulation.png\",\"keywords\":[\"medtech\",\"medtech\"],\"articleSection\":[\"Corporate\",\"MedTech\"],\"inLanguage\":\"de\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.teoresigroup.com\\\/de\\\/news\\\/medical-device-functional-safety-connecting-mdr-and-the-machinery-regulation\\\/\",\"url\":\"https:\\\/\\\/www.teoresigroup.com\\\/de\\\/news\\\/medical-device-functional-safety-connecting-mdr-and-the-machinery-regulation\\\/\",\"name\":\"Medical device functional safety: connecting MDR and the Machinery Regulation\u00a0 - Teoresi Group\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.teoresigroup.com\\\/it\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.teoresigroup.com\\\/de\\\/news\\\/medical-device-functional-safety-connecting-mdr-and-the-machinery-regulation\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.teoresigroup.com\\\/de\\\/news\\\/medical-device-functional-safety-connecting-mdr-and-the-machinery-regulation\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.teoresigroup.com\\\/wp-content\\\/uploads\\\/2026\\\/10\\\/medical-device-functional-safety-connecting-mdr-and-the-machinery-regulation.png\",\"datePublished\":\"2026-10-29T11:22:51+00:00\",\"dateModified\":\"2026-10-29T11:29:07+00:00\",\"description\":\"Discover all you need to know about Medical device functional safety: connecting MDR and the Machinery Regulation\u00a0 on Teoresi Group - Teoresi Group is high profile engineering. 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