Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices

Elahi, B. (TU Delft Energy Technology; Drexel University; Eindhoven University of Technology)

2022

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.

http://resolver.tudelft.nl/uuid:3f1ce1e8-e567-4538-bc9a-c5e92781d94c

https://doi.org/10.1016/B978-0-323-85755-0.00042-4

Elsevier

978-032391823-7

2023-07-01

2nd

Green Open Access added to TU Delft Institutional Repository 'You share, we take care!' - Taverne project https://www.openaccess.nl/en/you-share-we-take-care Otherwise as indicated in the copyright section: the publisher is the copyright holder of this work and the author uses the Dutch legislation to make this work public.

Institutional Repository

book

© 2022 B. Elahi