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Mastering Safety Risk Management for Medical and In Vitro Devices by Jayet Moon at Abbey's Bookshop,
Mastering Safety Risk Management for Medical and In Vitro Devices
— —
Jayet Moon Arun Mathew

Mastering Safety Risk Management for Medical and In Vitro Devices

Jayet Moon,  Arun Mathew

$179.95   $144.16

Paperback

Not in-store but you can order this
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English
ASQ Quality Press
10 May 2024
Management accounting & bookkeeping; Manufacturing industries; Medical administration & management
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).
By:   ,
Imprint:   ASQ Quality Press
Dimensions:   Height: 229mm,  Width: 152mm,  Spine: 16mm
Weight:   413g
ISBN:   9781636941707
ISBN 10:   1636941702
Pages:   306
Publication Date:  
Audience:   General/trade ,  ELT Advanced
Format:   Paperback
Publisher's Status:   Active

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