{"id":27768,"date":"2025-03-07T09:14:02","date_gmt":"2025-03-07T09:14:02","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?post_type=news&#038;p=27768"},"modified":"2026-09-03T14:23:17","modified_gmt":"2026-09-03T14:23:17","slug":"guidance-risks-software-medical-devices","status":"publish","type":"news","link":"https:\/\/quickbirdmedical.com\/en\/news\/guidance-risks-software-medical-devices\/","title":{"rendered":"Guidance on Assessing Risks in Software Medical Devices Published"},"content":{"rendered":"<p><strong>The International Medical Device Regulators Forum<\/strong> (IMDRF) is a voluntary association of medical device regulators from around the world.<\/p>\n<p class=\"last-child\">At the end of January, the IMDRF published a <strong>practical guidance document<\/strong> on classifying <strong>risks in software medical devices<\/strong>.<\/p>\n<p><a href=\"https:\/\/www.imdrf.org\/documents\/characterization-considerations-medical-device-software-and-software-specific-risk\/\"><img decoding=\"async\" class=\"alignnone wp-image-18700 size-full\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/03\/leitfaden-risiken-software-medizinprodukte-scaled.webp\" alt=\"guidance on risks in software medical devices\" width=\"2560\" height=\"2560\" srcset=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/03\/leitfaden-risiken-software-medizinprodukte-scaled.webp 2560w, https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/03\/leitfaden-risiken-software-medizinprodukte-1280x1280.webp 1280w, https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/03\/leitfaden-risiken-software-medizinprodukte-980x980.webp 980w, https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/03\/leitfaden-risiken-software-medizinprodukte-480x480.webp 480w\" sizes=\"(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) and (max-width: 1280px) 1280px, (min-width: 1281px) 2560px, 100vw\" \/><\/a><\/p>\n<p>The guidance is available for download on the IMDRF website: <a href=\"https:\/\/www.imdrf.org\/documents\/characterization-considerations-medical-device-software-and-software-specific-risk\/\" target=\"_blank\" rel=\"noopener\">Characterization Considerations for Medical Device Software and Software-Specific Risk<\/a><\/p>\n","protected":false},"featured_media":0,"template":"","categories":[],"tags":[],"display":[54],"class_list":["post-27768","news","type-news","status-publish","hentry","display-display-on-news-page"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>New Guidance: Risk Classification of Medical Software<\/title>\n<meta name=\"description\" content=\"IMDRF issues new guidance on characterizing risks and intended purpose for medical device 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