Jayet Moon News Today

In the context of ISO 14971:2019 and risk management for medical devices, manufacturers and designers are often confused about the implementation of...

The EU's Medical Device Regulation refers to a benefit-risk ratio multiple times, especially with respect to clinical evaluation and in Sections...

This article focuses on failure modes and effects and criticality analysis (FMECA) and the hazard-based approach in ISO 14971. It uses these...

In Part 1 of this 2-part series, the authors presented a method by which benefit-risk analysis can be objectively carried out to arrive at a...

This article introduces a novel model of benefit-risk by taking a bottom-up approach using the _risk of the therapy_ and comparing it to _risk of no...

This article introduces a novel model of benefit-risk by taking a bottom-up approach using the _risk of the therapy_ and comparing it to _risk of no...

. 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.  . It not only explores the interfaces between risk management and PMS but also discusses the postmarket aspects of risk surveillance and their accomplishments. Part 4 details an important upcoming topic ...

Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: The Binding Thread Of Risk Management By Jayet Moon, author of the book 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. This four-part series, using a fresh perspective, takes a bottom-up approach to PMS and starts by elaborating on the state of the art on the incident investigations in Part 1 . “In...

Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: A Systems Approach By Jayet Moon, author of the book 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. This four-part series, using a fresh perspective, takes a bottom-up approach to PMS and starts by elaborating on the state of the art on the incident investigations in Part 1 . “Investigations” are t...