From the Back Cover
Safety Risk Management for Medical Devices 2nd Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. It also removes the uncertainties associated with the understanding and application of international standards. Focusing exclusively on the 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 practice. This book comprehensively addresses safety risk management from the standpoint of a wide variety of medical devices, making it useful for those 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.
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 commercialising medical devices in line with the most current international standards and regulations. The new edition also offers guidance on navigating the changes in the EU medical approval process. Readers using the new edition will find new chapters on risk management for suppliers, residual risk and risk management review. This second edition features 30 new chapters/sections, and 25 updated chapters/sections.
About the Author
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.
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