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Mastering Safety Risk Management for Medical and In Vitro Devices
by [Moon, Jayet, Mathew, Arun]
$67.45
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Description
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).
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Product Details
- ASQ Quality Press Brand
- May 10, 2024 Pub Date:
- 9781636941707 ISBN-13:
- 1636941702 ISBN-10:
- English Language
- 9 in * 0.64 in * 6 in Dimensions:
- 1 lb Weight:
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