By Jayet Moon, author of the book Foundations of Quality Risk Management
As the central focus of the EU’s Medical Device Regulations (MDR), postmarket surveillance (PMS) and its related processes and subsystems have been in the limelight since 2017. Jayet Moon, author of the book Foundations of Quality Risk Management, takes a bottom-up approach to PMS with this e-book.
He starts by elaborating on the state of the art in incident investigations. “Investigations” are the basic iota of the PMS system upon which all further analysis, synthesis, and decision-making is based. With clarity on this most fundamental unit of PMS, Mr. Moon goes on to explore how successful implementation of an effective EU MDR-compliant PMS requires a systems approach, which requires appreciation of not only the organizational context within which PMS operates but also the knowledge management as it relates to PMS generated data, information, knowledge, and wisdom. Mr. Moon then focuses on the bedrock of EU MDR: the risk management system. He not only examines the interfaces between risk management and PMS but also discusses the postmarket aspects of risk surveillance and their accomplishments. Lastly, he details risk-based incident trending for postmarket signal detection, which is quickly becoming an expectation from most regulatory agencies and EU MDR is one of the first regulations to expressly document this requirement. The regulation asks for a methodology to gauge “statistically significant increases” in a certain subset of postmarket incidents, and Mr. Moon details salient features of any such method.
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