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Safety Risk Management for Medical Devices


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Table of Contents

Why do risk management? Fundamentals of risk management Understanding risk Risk Management standards Requirements of a compliant risk management process Quality management system Usability engineering and risk management Biocompatibility and risk management Risk management process Risk analysis techniques Safety vs. reliability Influence of security on safety Software risk management Integration of risk analyses Risk estimation Risk controls Risk evaluation Risk assessment and control table On testing Verification of risk controls Benefit-risk analysis Production and post-production monitoring Traceability Risk management for clinical investigations Risk management for legacy devices Relationship between ISO 14971 and other safety standards Risk management process metrics Risk management and product development process Critical thinking and risk management Advice and wisdom

About the Author

Bijan Elahi is an expert in risk management and systems engineering and the winner of the Educator of the Year Award from the International System Safety Society. Mr. Elahi's mission is to elevate knowledge and proficiency in medical device risk management via teaching, coaching, and mentoring. He has over 25 years of experience in risk management working at the largest medical device companies in the world, as well as small start-ups. He is also a lecturer at Eindhoven University of Technology (the Netherlands), where he teaches risk management to doctoral students in engineering. Mr. Elahi is a Technical Fellow at Medtronic, and a contributor to the international standard ISO 14971-"Medical devices-Application of risk management to medical devices." He is a member of the Editorial Board of the Journal of System Safety, a publication of the International System Safety Society, and a frequently invited speaker and lecturer at international conferences. Previously, he was a systems engineer on the Space Shuttle at NASA, United States. He holds an MS Electrical Engineering degree from the University of Washington and a BS Aerospace Engineering degree from Iowa State University, United States.

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