Products
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eLearning: Risk Management for Medical Devices
CourseLearn to apply ISO 14971 risk management to medical devices and IVDs. Identify hazards, assess and control risks, use tools such as FMEA and fault tree analysis, and develop risk management plans, reports and files.
$595
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eLearning: Human Factors and Usability Engineering in Medical Device Development
CourseLearn to apply human factors and usability engineering throughout medical device development. Identify use-related risks, plan usability evaluations, and prepare documentation using FDA guidance and IEC 62366-1.
$595
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Medical Device Human Factors & Usability Engineering: 2026 Update
CourseExplore changes in medical device human factors and usability engineering: FDA submissions, global regulations, standards and AI-enabled devices. Apply the updates through practical examples. Prior human factors knowledge recommended.
$249
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eLearning: Software Validation for Medical Devices
CourseLearn to plan and document software verification and validation for medical devices, digital health apps, manufacturing and quality systems. Apply FDA guidance and relevant standards through practical medical device assignments.
$595
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eLearning: IEC 62304 Medical Device Software — software lifecycle processes
CourseThis course is suitable for anyone that participates in planning, designing and testing medical device software. The course covers the relationship between the IEC 62304 and other standards, compares and contrasts IEC 62304 with FDA expectations.
$299