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Mastering Safety Risk Management for Medical and In Vitro Devices by Jayet Moon
Mastering Safety Risk Management for Medical and In Vitro Devices by Jayet Moon
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Mastering Safety Risk Management for Medical and In Vitro Devices

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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).
Release date Australia
May 10th, 2024
Audience
  • General (US: Trade)
Pages
306
Dimensions
152x229x16
ISBN-13
9781636941707
Product ID
38863937

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