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Join date: Jan 18, 2020
Posts (28)
Jun 27, 2025 ∙ 8 min
Understanding Use-Related Risk Analysis (URRA) and Use-Failure Modes and Effects Analysis (uFMEA) in Medical Device Development
Understanding Use-Related Risk Analysis (URRA) and Use-Failure Modes and Effects Analysis (uFMEA) in Medical Device Development
Part I - Introduction: Why Risk Analysis Matters in Medical Device Development
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Mar 4, 2025 ∙ 2 min
Ep.012 Safe and Effective Podcast: FDA Regulatory Roundup: CDER Human Factors ANDA Draft Guidance (ft. Melissa Lemke)
Podcast on FDA Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product in an ANDA.
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Feb 27, 2025 ∙ 7 min
Breaking into Medical Human Factors: A Guide for Aspiring Human Factors Engineers
Breaking into Medical Human Factors: A Guide for Aspiring Human Factors Engineers
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