Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle the difficult questions, such as how to define risk acceptance criteria and how to determine when to stop risk reduction.
This book delivers not only theory, but also practical guidance for applying the theory in daily risk management work. The reader is familiarized with the vocabulary of risk management and guided through a process to ensure compliance with the international standard ISO 14971-a requirement for all medical devices. This book outlines sensible, easily comprehensible, and state-of the-art methodologies that are rooted in current industry best practices.
Opening chapters introduce the concept of risk, the legal basis for risk management, and the requirements for a compliant risk-management process. The next group of chapters discusses the connection between risk management and quality systems, usability engineering and biocompatibility. This book delves into the techniques of risk management, such as fault tree analysis and failure modes and effects analysis, and continues with risk estimation, risk control, and risk evaluation. Special topics such as software risk management, clinical investigations, and security are also discussed. The latter chapters address benefit-risk analysis, and production and postproduction monitoring. This book concludes with advice and wisdom for sensible, efficient, and successful safety risk management of medical devices.
- Teaches industry best practices on medical-device risk management in compliance with ISO 14971
- Provides practical, easy-to-understand, and step-by-step instructions on how to perform hazard analysis and manage the risks of medical devices
- Offers a worked-out example applying the risk management process on a hypothetical device
- 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
- 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
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.