Safety Risk Management for Medical Devices

Bijan Elahi

• Publisher: Academic Press
• Year: 2018
• ISBN:
  9780128130995
• Topic: Tecnologia e ingegneria
• Subtopic: Scienza biomedica

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

Table of contents

• Cover image
• Title page
• Table of Contents
• Copyright
• Dedication
• List of Figures
• List of Tables
• Biography
• Preface
• Chapter 1. Introduction
• Chapter 2. Why Do Risk Management?
• Chapter 3. The Basics
• Chapter 4. Understanding Risk
• Chapter 5. Risk Management Standards
• Chapter 6. Requirements of the Risk Management Process
• Chapter 7. Quality Management System
• Chapter 8. Usability Engineering and Risk Analysis
• Chapter 9. Biocompatibility and Risk Management
• Chapter 10. The BXM Method
• Chapter 11. Risk Management Process
• Chapter 12. Risk Analysis Techniques
• Chapter 13. Safety Versus Reliability
• Chapter 14. Influence of Security on Safety
• Chapter 15. Software Risk Management
• Chapter 16. Integration of Risk Analysis
• Chapter 17. Risk Estimation
• Chapter 18. Risk Controls
• Chapter 19. Risk Evaluation
• Chapter 20. Risk Assessment and Control Table
• Chapter 21. On Testing
• Chapter 22. Verification of Risk Controls
• Chapter 23. Benefit–Risk Analysis
• Chapter 24. Production and Postproduction Monitoring
• Chapter 25. Traceability
• Chapter 26. Risk Management for Clinical Investigations
• Chapter 27. Risk Management for Legacy Devices
• Chapter 28. Basic Safety and Essential Performance
• Chapter 29. Relationship Between ISO 14971 and Other Standards
• Chapter 30. Risk Management Process Metrics
• Chapter 31. Risk Management and Product Development Process
• Chapter 32. Axioms
• Chapter 33. Special Topics
• Chapter 34. Critical Thinking and Risk Management
• Chapter 35. Advice and Wisdom
• Appendix A. Glossary
• Appendix B. Templates
• Appendix C. Example Device—Vivio
• Appendix D. NBRG Consensus Paper
• References
• Index