By Jayet Moon, author of the book Foundations of Quality Risk Management
The thread of risk management connects every piece in the quality management system and guides the manufacturer in quality-related decision-making throughout the lifecycle of the device. In Part 3 of his article series on risk-based post-market surveillance (PMS) in the age of EU MDR, Jayet Moon discusses how quality risk management and PMS are natural partners. He also examines the five elements for which the PMS system should be on the lookout.
|