ARTICLES BY JAYET MOON
Risk Intelligence And Risk-Based Decision-Making: Combining Strategic Risk Management With Safety Risk Management
You’re familiar with ISO 14971, the “Application of Risk Management to Medical Devices” standard. Upon closer inspection, you’ll learn that this standard is in fact a standard for medical device safety risk management. However, risk management goes beyond the product safety aspects and includes strategic and operational elements. This article discusses how risk managed at one level allows for opportunities for value creation at other levels.
Risk-Based Postmarket Surveillance In The Age Of EU MDR
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.
Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: Risk-Based Trending
Risk-based incident trending for postmarket signal detection is quickly becoming an expectation from most regulatory agencies and EU MDR is one of the first regulations to expressly document this requirement. Jayet Moon concludes his four-part article series on risk-based postmarket surveillance in the age of EU MDR by examining the salient features of a sound risk-based trending process and methodology and discussing what to look for in a trend analysis.
Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: The Binding Thread Of 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 postmarket 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.
Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: A Systems Approach
Jayet Moon continues his four-part series on risk-based postmarket surveillance in the age of the EU Medical Device Regulations (MDR) with Part 2, which delves into the systems approach. Such an approach gives due consideration to process interfaces with other organizational functions and knowledge management. It would not only make compliance to EU MDR easy but also make the organizational processes much more effective and efficient.
Risk-Based Postmarket Surveillance In The Age Of EU MDR: Incident Investigation
Jayet Moon begins this four-part series on risk-based postmarket surveillance (PMS) in the age of EU MDR by delving into the incident investigation. Such investigations are the basic iota of the PMS system upon which all further analysis, synthesis, and decision-making is based. By looking into the Who? What? When? Where? Why? and How? of serious events related to your device, you'll be able to provide answers to regulatory bodies.