{"id":8545,"date":"2026-08-10T09:57:18","date_gmt":"2026-08-10T09:57:18","guid":{"rendered":"https:\/\/nokobox.com\/index.php\/item\/udemy-applying-iso-14971-risk-management-to-medical-devices-2025-2\/"},"modified":"2026-08-10T09:57:18","modified_gmt":"2026-08-10T09:57:18","slug":"udemy-applying-iso-14971-risk-management-to-medical-devices-2025-2","status":"publish","type":"digital_item","link":"https:\/\/nokobox.com\/index.php\/item\/udemy-applying-iso-14971-risk-management-to-medical-devices-2025-2\/","title":{"rendered":"Udemy \u2013 Applying ISO 14971 Risk Management to Medical Devices 2025-2"},"content":{"rendered":"<div class=\"w-post-elm post_content\">\n<h2 dir=\"ltr\" style=\"text-align: left\"><span style=\"vertical-align: inherit\">Description<\/span><\/h2>\n<p dir=\"ltr\" style=\"text-align: left\" data-sourcepos=\"7:1-7:478\"><span style=\"vertical-align: inherit\">Applying ISO 14971 Risk Management to Medical Devices course. This comprehensive course teaches you how to use the AAMI\/BSI TR 34971 and ISO 14971 standards to manage risk in AI-enabled medical devices. You will learn how these global frameworks ensure safety, compliance, and quality throughout the product lifecycle. By focusing on AI-specific challenges such as algorithmic bias, model switching, and data integrity, participants will gain valuable insights into mitigating risks associated with AI technologies in healthcare.<\/span><\/p>\n<h3 dir=\"ltr\" style=\"text-align: left\" data-sourcepos=\"9:1-9:25\"><span style=\"vertical-align: inherit\">What you will learn:<\/span><\/h3>\n<ul dir=\"ltr\" style=\"text-align: left\" data-sourcepos=\"11:1-16:0\">\n<li data-sourcepos=\"11:1-11:148\"><span style=\"vertical-align: inherit\">Understanding the specific risk management of AI in medical devices: Gain an in-depth understanding of the unique challenges and risks associated with AI-based medical devices.<\/span><\/li>\n<li data-sourcepos=\"12:1-12:162\"><span style=\"vertical-align: inherit\">Understanding the legal requirements for AI-based medical devices: Learn about the laws and regulations related to AI-based medical devices and how to comply with them.<\/span><\/li>\n<li data-sourcepos=\"13:1-13:141\"><span style=\"vertical-align: inherit\">Implementing a Comprehensive Risk Management Process: Learn how to create and implement a comprehensive risk management process for AI-based medical devices.<\/span><\/li>\n<li data-sourcepos=\"14:1-14:117\"><span style=\"vertical-align: inherit\">Identify and mitigate AI-specific risks: Learn how to identify and mitigate risks such as algorithmic bias and model switching.<\/span><\/li>\n<li data-sourcepos=\"15:1-16:0\"><span style=\"vertical-align: inherit\">Ensure post-sale monitoring and continuous improvement: Understand the importance of monitoring the performance of devices after they enter the market and continuously improve risk management processes.<\/span><\/li>\n<\/ul>\n<h3 dir=\"ltr\" style=\"text-align: left\" data-sourcepos=\"17:1-17:32\"><span style=\"vertical-align: inherit\">Who is this course suitable for?<\/span><\/h3>\n<ul dir=\"ltr\" style=\"text-align: left\" data-sourcepos=\"19:1-23:0\">\n<li data-sourcepos=\"19:1-19:206\"><span style=\"vertical-align: inherit\">Regulatory professionals: Individuals working in medical device regulatory compliance who need to understand the application of ISO 14971 and AAMI\/BSI TR 34971 standards to manage specific AI risks.<\/span><\/li>\n<li data-sourcepos=\"20:1-20:214\"><span style=\"vertical-align: inherit\">Quality Assurance and Risk Management Professionals: Professionals responsible for ensuring the safety, quality, and performance of medical devices and who want to implement a comprehensive risk management process for AI-based devices.<\/span><\/li>\n<li data-sourcepos=\"21:1-21:266\"><span style=\"vertical-align: inherit\">Medical Device Developers and Engineers: Engineers and developers involved in creating or updating AI-based medical devices and want to gain important insights into how to identify and mitigate AI-specific risks such as algorithmic bias and model switching.<\/span><\/li>\n<li data-sourcepos=\"22:1-23:0\"><span style=\"vertical-align: inherit\">Healthcare and AI enthusiasts: People who are interested in AI and healthcare innovation and want to learn about the intersection of AI technology with medical device regulations, safety standards, and risk management.<\/span><\/li>\n<\/ul>\n<h3 dir=\"ltr\" style=\"text-align: left\"><span style=\"vertical-align: inherit\">Course details: Applying ISO 14971 Risk Management to Medical Devices<\/span><\/h3>\n<ul dir=\"ltr\" style=\"text-align: left\">\n<li><span style=\"vertical-align: inherit\">Publisher:&nbsp; <\/span><a href=\"https:\/\/href.li\/?https:\/\/www.udemy.com\/course\/artificial-intelligence-risk-management-for-medical-device\/?couponCode=LEARNNOWPLANSGB\" target=\"_blank\" rel=\"noopener\"><span style=\"vertical-align: inherit\">Udemy<\/span><\/a><\/li>\n<li><span style=\"vertical-align: inherit\">Instructor:&nbsp; <\/span><a class=\"ud-btn ud-btn-large ud-btn-link ud-heading-md ud-text-sm ud-instructor-links\" href=\"https:\/\/downloadlynet.ir\/tag\/eqms-innovation\/\" data-position=\"1\"><span class=\"ud-btn-label\"><span style=\"vertical-align: inherit\">eQMS Innovation<\/span><\/span><\/a><\/li>\n<li><span style=\"vertical-align: inherit\">Training level: Beginner to advanced<\/span><\/li>\n<li><span style=\"vertical-align: inherit\">Training duration: 1 hour and 4 minutes<\/span><\/li>\n<li><span style=\"vertical-align: inherit\">Number of lessons: 13<\/span><\/li>\n<\/ul>\n<h3 dir=\"ltr\" style=\"text-align: left\"><span style=\"vertical-align: inherit\">Course headings<\/span><\/h3>\n<h3 dir=\"ltr\" style=\"text-align: left\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-962199 size-full\" src=\"https:\/\/downloadly.ir\/wp-content\/uploads\/2025\/02\/Applying-ISO-14971-Risk-Management-to-Medical-Devices-1.png\" alt=\"Applying ISO 14971 Risk Management to Medical Devices\" width=\"884\" height=\"585\"><\/h3>\n<h3 dir=\"ltr\" style=\"text-align: left\"><span style=\"vertical-align: inherit\">Prerequisites for the Applying ISO 14971 Risk Management to Medical Devices course<\/span><\/h3>\n<ul dir=\"ltr\" style=\"text-align: left\">\n<li dir=\"ltr\" style=\"text-align: left\"><span style=\"vertical-align: inherit\">Basic Understanding of Medical Devices and AI Learners should have a fundamental understanding of medical devices and how artificial intelligence (AI) is used in healthcare applications. Familiarity with basic AI concepts, such as machine learning models and their applications, is helpful but not mandatory.<\/span><\/li>\n<li dir=\"ltr\" style=\"text-align: left\"><span style=\"vertical-align: inherit\">Familiarity with Risk Management Principles Some experience with risk management or quality assurance processes (in any industry) would be beneficial. This includes concepts like risk assessment, mitigation strategies, and compliance.<\/span><\/li>\n<li dir=\"ltr\" style=\"text-align: left\"><span style=\"vertical-align: inherit\">Eagerness to learn No prior experience with ISO 14971 or AAMI\/BSI TR 34971 is required. Beginners are welcome, and the course will cover all key concepts, standards, and practices needed to understand and manage risk in AI-based medical devices.<\/span><\/li>\n<\/ul>\n<h3 dir=\"ltr\" style=\"text-align: left\"><span style=\"vertical-align: inherit\">Course images<\/span><\/h3>\n<h3 dir=\"ltr\" style=\"text-align: left\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-962200 size-full\" src=\"https:\/\/downloadly.ir\/wp-content\/uploads\/2025\/02\/Applying-ISO-14971-Risk-Management-to-Medical-Devices.png\" alt=\"Applying ISO 14971 Risk Management to Medical Devices\" width=\"804\" height=\"413\"><\/h3>\n<h3 dir=\"ltr\" style=\"text-align: left\"><span style=\"vertical-align: inherit\">Sample course video<\/span><\/h3>\n<div style=\"width: 640px;\" class=\"wp-video\"><span class=\"mejs-offscreen\">Video Player<\/span><\/p>\n<div id=\"mep_0\" class=\"mejs-container mejs-container-keyboard-inactive wp-video-shortcode mejs-video\" tabindex=\"0\" role=\"application\" aria-label=\"Video Player\" style=\"width: 640px; height: 360px; min-width: 217px;\">\n<div class=\"mejs-inner\">\n<div class=\"mejs-mediaelement\"><mediaelementwrapper id=\"video-154058-1\"><video class=\"wp-video-shortcode\" id=\"video-154058-1_html5\" width=\"640\" height=\"360\" preload=\"metadata\" src=\"https:\/\/dl.downloadly.ir\/Files\/Elearning\/Sample\/Applying_ISO_14971_Risk_Management_to_Medical_Devices_Downloadly.ir.mp4?_=1\" style=\"width: 640px; height: 360px;\"><source type=\"video\/mp4\" src=\"https:\/\/dl.downloadly.ir\/Files\/Elearning\/Sample\/Applying_ISO_14971_Risk_Management_to_Medical_Devices_Downloadly.ir.mp4?_=1\"><a href=\"https:\/\/dl.downloadly.ir\/Files\/Elearning\/Sample\/Applying_ISO_14971_Risk_Management_to_Medical_Devices_Downloadly.ir.mp4?nocache=1786112571553\">https:\/\/dl.downloadly.ir\/Files\/Elearning\/Sample\/Applying_ISO_14971_Risk_Management_to_Medical_Devices_Downloadly.ir.mp4<\/a><\/video><\/mediaelementwrapper><\/div>\n<div class=\"mejs-layers\">\n<div class=\"mejs-poster mejs-layer\" style=\"display: none; width: 100%; height: 100%;\"><\/div>\n<div class=\"mejs-overlay mejs-layer\" style=\"display: none; width: 100%; height: 100%;\">\n<div class=\"mejs-overlay-loading\"><span class=\"mejs-overlay-loading-bg-img\"><\/span><\/div>\n<\/div>\n<div class=\"mejs-overlay mejs-layer\" style=\"display: none; width: 100%; height: 100%;\">\n<div class=\"mejs-overlay-error\"><\/div>\n<\/div>\n<div class=\"mejs-overlay mejs-layer mejs-overlay-play\" style=\"width: 100%; height: 100%;\">\n<div class=\"mejs-overlay-button\" role=\"button\" tabindex=\"0\" aria-label=\"Play\" aria-pressed=\"false\"><\/div>\n<\/div>\n<\/div>\n<div class=\"mejs-controls\">\n<div class=\"mejs-button mejs-playpause-button mejs-play\"><button type=\"button\" aria-controls=\"mep_0\" title=\"Play\" aria-label=\"Play\" tabindex=\"0\"><\/button><\/div>\n<div class=\"mejs-time mejs-currenttime-container\" role=\"timer\" aria-live=\"off\"><span class=\"mejs-currenttime\">00:00<\/span><\/div>\n<div class=\"mejs-time-rail\"><span class=\"mejs-time-total mejs-time-slider\" role=\"slider\" tabindex=\"0\" aria-label=\"Time Slider\" aria-valuemin=\"0\" aria-valuemax=\"0\" aria-valuenow=\"0\" aria-valuetext=\"00:00\"><span class=\"mejs-time-buffering\" style=\"display: none;\"><\/span><span class=\"mejs-time-loaded\"><\/span><span class=\"mejs-time-current\"><\/span><span class=\"mejs-time-hovered no-hover\"><\/span><span class=\"mejs-time-handle\"><span class=\"mejs-time-handle-content\"><\/span><\/span><span class=\"mejs-time-float\"><span class=\"mejs-time-float-current\">00:00<\/span><span class=\"mejs-time-float-corner\"><\/span><\/span><\/span><\/div>\n<div class=\"mejs-time mejs-duration-container\"><span class=\"mejs-duration\">00:00<\/span><\/div>\n<div class=\"mejs-button mejs-volume-button mejs-mute\"><button type=\"button\" aria-controls=\"mep_0\" title=\"Mute\" aria-label=\"Mute\" tabindex=\"0\"><\/button><a href=\"javascript:void(0);\" class=\"mejs-volume-slider\" aria-label=\"Volume Slider\" aria-valuemin=\"0\" aria-valuemax=\"100\" role=\"slider\" aria-orientation=\"vertical\"><span class=\"mejs-offscreen\">Use Up\/Down Arrow keys to increase or decrease volume.<\/span><\/p>\n<div class=\"mejs-volume-total\">\n<div class=\"mejs-volume-current\" style=\"bottom: 0px; height: 100%;\"><\/div>\n<div class=\"mejs-volume-handle\" style=\"bottom: 100%; margin-bottom: -3px;\"><\/div>\n<\/div>\n<p><\/a><\/div>\n<div class=\"mejs-button mejs-fullscreen-button\"><button type=\"button\" aria-controls=\"mep_0\" title=\"Fullscreen\" aria-label=\"Fullscreen\" tabindex=\"0\"><\/button><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div dir=\"ltr\" style=\"text-align: left\">\n<h3><span style=\"vertical-align: inherit\">Installation Guide<\/span><\/h3>\n<p><span style=\"vertical-align: inherit\">After Extract, view with your favorite player.<\/span><\/p>\n<p><span style=\"vertical-align: inherit\">Subtitles: None<\/span><\/p>\n<p><span style=\"vertical-align: inherit\">Quality: 720p<\/span><\/p>\n<\/div>\n<h3 dir=\"ltr\" style=\"text-align: left\"><span style=\"vertical-align: inherit\">Download link<\/span><\/h3>\n<p dir=\"ltr\" style=\"text-align: left\"><a href=\"https:\/\/dl1.downloadly.ir\/Files\/Elearning\/Udemy_Applying_ISO_14971_Risk_Management_to_Medical_Devices_2025-2_Downloadly.ir.rar?nocache=1786112570\"><span style=\"vertical-align: inherit\">Download file \u2013 338 MB<\/span><\/a><\/p>\n<p dir=\"ltr\" style=\"text-align: left\"><span style=\"vertical-align: inherit\">File(s) password: www.downloadly.ir<\/span><\/p>\n<h3 dir=\"ltr\" style=\"text-align: left\"><span style=\"vertical-align: inherit\">File size<\/span><\/h3>\n<p dir=\"ltr\" style=\"text-align: left\"><span style=\"vertical-align: inherit\">338 MB<\/span><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Description Applying ISO 14971 Risk Management to Medical Devices course. This comprehensive course teaches you how to use the AAMI\/BSI TR 34971 and ISO 14971 s<\/p>\n","protected":false},"author":1,"template":"","dgi_category":[10458],"dgi_tag":[75360,75361,75362,63161,75363,75364],"class_list":["post-8545","digital_item","type-digital_item","status-publish","has-post-thumbnail","hentry","dgi_category-video-tutorials","dgi_tag-course-applying-iso-14971-risk-management-to-medical-devices","dgi_tag-download-applying-iso-14971-risk-management-to-medical-devices","dgi_tag-download-course-applying-iso-14971-risk-management-to-medical-devices","dgi_tag-eqms-innovation","dgi_tag-free-applying-iso-14971-risk-management-to-medical-devices","dgi_tag-free-download-applying-iso-14971-risk-management-to-medical-devices"],"_links":{"self":[{"href":"https:\/\/nokobox.com\/index.php\/wp-json\/wp\/v2\/digital_item\/8545","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nokobox.com\/index.php\/wp-json\/wp\/v2\/digital_item"}],"about":[{"href":"https:\/\/nokobox.com\/index.php\/wp-json\/wp\/v2\/types\/digital_item"}],"author":[{"embeddable":true,"href":"https:\/\/nokobox.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"version-history":[{"count":0,"href":"https:\/\/nokobox.com\/index.php\/wp-json\/wp\/v2\/digital_item\/8545\/revisions"}],"wp:attachment":[{"href":"https:\/\/nokobox.com\/index.php\/wp-json\/wp\/v2\/media?parent=8545"}],"wp:term":[{"taxonomy":"dgi_category","embeddable":true,"href":"https:\/\/nokobox.com\/index.php\/wp-json\/wp\/v2\/dgi_category?post=8545"},{"taxonomy":"dgi_tag","embeddable":true,"href":"https:\/\/nokobox.com\/index.php\/wp-json\/wp\/v2\/dgi_tag?post=8545"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}