Safety Risk Management for Medical Devices
Language: English
Published by Academic Press, 2021
- Softcover
- Used

Condition: Used - Very good
£ 57.03
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534 Seiten; 9780323857550.3 Gewicht in Gramm: 2.
Seller Inventory # 1343619
- Title
- Safety Risk Management for Medical Devices
- Author
- Elahi, Bijan:
- Publisher
- Academic Press
- Publication year
- 2021
- Condition
- Gut
- Binding
- paperback
- Language
- English
- ISBN 10
- 0323857558
- ISBN 13
- 9780323857550
- Edition
- 2nd Edition
- Item weight
- 2 grams
- Seller catalogs
- Varia
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.
- Includes new coverage of ISO 14971:2019, ISO/TR 24971
- Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management
- Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation
"Synopsis" may belong to another edition of this title.
About the Author
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.
"About the title" may belong to another edition of this title.
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