Safety Risk Management for Medical Devices

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

Engineers and other professionals in the MedTech sector who need to know about safety risk management (including design engineers, product engineers, development engineers, software engineers); Quality assurance and regulatory affairs staff in medical device companies; Graduate level biomedical engineering students with an interest in medical devices

1. Why do risk management?
2. Fundamentals of risk management
3. Understanding risk
4. Risk Management standards
5. Requirements of a compliant risk management process
6. Quality management system
7. Usability engineering and risk management
8. Biocompatibility and risk management
9. Risk management process
10. Risk analysis techniques
11. Safety vs. reliability
12. Influence of security on safety
13. Software risk management
14. Integration of risk analyses
15. Risk estimation
16. Risk controls
17. Risk evaluation
18. Risk assessment and control table
19. On testing
20. Verification of risk controls
21. Benefit-risk analysis
22. Production and post-production monitoring
23. Traceability
24. Risk management for clinical investigations
25. Risk management for legacy devices
26. Relationship between ISO 14971 and other safety standards
27. Risk management process metrics
28. Risk management and product development process
29. Critical thinking and risk management
30. Advice and wisdom