Mastering Safety Risk Management for Medical and In Vitro Devices
Language: English
Published by ASQ Quality Press, 2024
- Softcover
- New
Condition: New
£ 78.73
Quantity: 2 available
Add to basketItem description from seller
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). Sprache: Englisch Gewicht in Gramm: 446.
Seller Inventory # IB-9829255
- Title
- Mastering Safety Risk Management for Medical and In Vitro Devices
- Author
- Jayet Moon, Arun Mathew
- Publisher
- ASQ Quality Press
- Publication year
- 2024
- Condition
- Neu
- Binding
- Softcover/Taschenbuch
- Language
- English
- ISBN 10
- 1636941702
- ISBN 13
- 9781636941707
- Item weight
- 446 grams
"Synopsis" may belong to another edition of this title.
Shipping rates from Germany to U.S.A.
| Item | 10 to 12 business days | 8 to 10 business days |
|---|---|---|
| First item | £ 41.62 | £ 62.56 |
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