Mastering Safety Risk Management for Medical and In Vitro Devices (eBook)

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). 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).