Safety Risk Management For Medical Devices
Download book entitled Safety Risk Management for Medical Devices written by Bijan Elahi and published by Academic Press. This book was released on 11 November 2021 with total pages 534. Available in PDF, EPUB and Kindle. Click GET THIS BOOK Button and find your favorite books in the library. Create free account to access unlimited books, fast download and ads free!
- Author : Bijan Elahi
- Release Date : 11 November 2021
- Publisher : Academic Press
- Genre : Technology & Engineering
- Pages : 534
- ISBN 13 : 9780323918237
Download Safety Risk Management for Medical Devices eBook in PDF, Epub and Kindle
Book Description: 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