Open Daily: 10am - 10pm | Alley door pickup 10am - 7pm 3038 Hennepin Ave Minneapolis, MN
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  • Open Daily: 10am - 10pm
    Alley-side Pickup: 10am - 7pm

    3038 Hennepin Ave Minneapolis, MN
    612-822-4611

Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
Mastering Safety Risk Management for Medical and In Vitro Devices

Mastering Safety Risk Management for Medical and In Vitro Devices

Moon, Jayet
Mathew, Arun

Paperback

AccountingBusiness GeneralMedical Reference

ISBN10: 1636941702
ISBN13: 9781636941707
Publisher: ASQ Quality Press
Published: May 10 2024
Pages: 306
Weight: 0.91
Height: 0.64 Width: 6.00 Depth: 9.00
Language: English
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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