Mastering Safety Risk Management for Medical and In Vitro Devices

Bys: Moon, Jayet and Mathew, Arun

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).

• Format: Paperback
• Language: English
• ISBN: 1636941702
• ISBN13: 9781636941707
• Release Date: May 2024
• Publisher: ASQ Quality Press
• Length: 306 Pages
• Weight: 0.91 lbs.
• Dimensions: 0.6" x 6.0" x 9.0"