Mastering Safety Risk Management for Medical and In Vitro Devices (Original PDF from Publisher)

By Jayet Moon, Arun Mathew
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).

Product Details

• ASIN ‏ : ‎ B0D5FYMLL3
• Publisher ‏ : ‎ ASQ Quality Press (10 May 2024)
• Language ‏ : ‎ English