Mastering Safety Risk Management For Medical And In Vitro Devices
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Mastering Safety Risk Management for Medical and In Vitro Devices
Author | : Jayet Moon |
Publisher | : Quality Press |
Total Pages | : 305 |
Release | : 2024-05-10 |
Genre | : Business & Economics |
ISBN | : 1636941710 |
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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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