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MASTERING SAFETY RISK MANAGEMENT FOR MEDICAL AND IN VITRO DE IBD

ASQ QUALITY PRESS
05 / 2024
9781636941707
Inglés

Sinopsis

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).

PVP
84,68