Mastering Safety Risk Management for Medical and In Vitro Devices

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. Mastering Safety Risk Management for Medical and In Vitro Devices 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 U.S. FDA regulations (including the new FDA QMSR).

Jayet Moon, CQE, CQIA, and CQSP, has a M.S. in biomedical engineering, a B.S. in electrical engineering, an MBA degree, and is a PMI-RMP, CQI Chartered Quality Professional, ERMCP, and RIMS-CRMP. Moon was awarded the Australian Organization for Quality ‘Passion for Excellence’ Award and was recognized in 2021 as an ASQ ‘40 under 40’ Rising Star. He is a Fellow of International Institute for Safety and Risk Management (FIIRSM) and an industry expert on safety and post-market surveillance. He authored several articles and the Quality Press book, Foundations of Quality Risk Management (2020).

Arun Mathew, CQA, CQE, is the Quality System Owner for Quality Risk Management for AbbVie, Inc. Arun earned an Executive MBA from the Quantic School of Business Technology and a master’s degree from Coventry University in addition to a diploma in electronics. With over 20 years of experience in the medical devices and pharmaceutical industries, Arun has pioneered risk-based approaches in design control, verification and validation, process validation, CAPA, and other quality management systems within organizations. He won the 2022 ASQ Delaware J.M. Juran Award for achievements in quality risk management.