Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations.

Bijan Elahi is an expert on a world scale in safety risk management for medical technology. Mr. Elahi's mission is to elevate knowledge and proficiency in medical device risk management to the highest levels worldwide via teaching, coaching, and mentoring, for the benefit of companies and society. He has 30+ years of experience in risk management, working with the largest medical device companies in the world, as well as with small start-ups. He is a lecturer at Eindhoven University of Technology (the Netherlands), where he teaches a graduate-level course in medical device risk management. The audience for this education is doctoral students in engineering as well as physicians and professionals in the medical device sector. Additionally, Mr. Elahi is a lecturer at Drexel University in Philadelphia (USA), and at Delft University of Technology (Netherlands). He is the recipient of the Educator of the Year Award by the International System Safety Society. In 2019 he received an award in recognition of Outstanding Development of Analytical Methods to Support Medical Device System Safety. Mr. Elahi has a long history of medical device development spanning class III implantable pulse generators, electro-mechanical, and disposable devices. His most recent product was a Deep Brain Stimulator (DBS) implant for Parkinson's disease. The knowledge that he imparts in his book is rooted in state-of-the-art practical knowledge in medical device development. Mr. Elahi is a Technical Fellow and a corporate advisor at Medtronic. In this role, he teaches and consults on medical device risk management to all Medtronic business units worldwide, including China, India, Middle East, Europe and North America. Mr. Elahi is a contributor to ISO 14971, and a member of the Editorial Board of the Journal of System Safety, a publication of the International System Safety Society. Mr. Elahi is a frequently invited speaker and lecturer at international conferences. Earlier in his distinguished career, he was a systems engineer on the Space Shuttle at NASA (USA). Mr. Elahi holds an MS Electrical Engineering degree from the University of Washington and a BS Aerospace Engineering degree from Iowa State University, United States.

1 Introduction 2 What Is A Medical Device? 3 Why Do Risk-Management? 4 The Basics 5 Understanding Risk 6 Risk Management Standards 7 Requirements of the Risk Management Process 8 Quality Management System 9 Usability Engineering and Risk Analysis 10 Biocompatibility and Risk Management 11 Influence of Security on Safety 12 The BXM Method 13 Risk Management Process 14 Risk Analysis Techniques  15 Software Risk Management 16 Integration of Risk Analysis 17 Risk Estimation 18 Risk Controls 19 Verification of Risk Controls 20 On Testing 21 Risk Evaluation 22 Risk Assessment and Control Table (RACT) 23 Benefit-Risk Analysis 24 Risk Management Review 26 Traceability 27 Lifetime of a Medical Device 28 Safety versus Reliability 29 Risk Management for System of Systems 30 Risk Management for Clinical Investigations 31 Risk Management for Legacy Devices 32 Risk Management for Combination Medical Devices 33 Basic Safety and Essential Performance 34 Relationship between ISO 14971 and other Standards 35 Risk Management Process Metrics 36 Risk Management and Product Development Process 37 Risk Management for Suppliers 38 Axioms 39 Special Topics 40 Critical Thinking and Risk Management 41 Advice and Wisdom Appendix A - Glossary Appendix B - Templates Appendix C - Example Device - Vivio Appendix D - Useful References