Mastering Safety Risk Management for Medical and In Vitro Devices
Language: English
Published by ASQ Quality Press, 2024
- Softcover
- New

Seller: Ria Christie Collections, Uxbridge, United KingdomRia Christie Collections
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Softcover
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Seller Inventory # ria9781636941707_new
- Title
- Mastering Safety Risk Management for Medical and In Vitro Devices
- Author
- Moon, Jayet; Mathew, Arun
- Publisher
- ASQ Quality Press
- Publication year
- 2024
- Condition
- New
- Binding
- Soft cover
- Language
- English
- ISBN 10
- 1636941702
- ISBN 13
- 9781636941707
When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product's life cycle into production and post-market phases. This book offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485:2016, ISO 14971:2019, European Union MDR, IVDR, and US FDA regulations (including the new FDA QMSR).
"Synopsis" may belong to another edition of this title.
Ria Christie Collections
Uxbridge, United Kingdom
5-star seller
AbeBooks seller since March 25, 2015
Shipping rates from United Kingdom to U.S.A.
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