Post-Market Surveillance

Post-market surveillance (PMS) methods can be strategically improved, providing a responsive approach to better manage patient safety, and mitigate patient harm. How?

External product ‘quality’ is measured in terms of high-harm nonconformity and the targeted failure mode is strategically linked to specific ‘critical to quality’ (CtQ) production control(s). This approach enables the retrospective identification and management of essential design outputs that may have gone undetected during product development and in the transfer of new products to the production environment.

The EU MDR requires a substantial change in oversight to maintain the risk-benefit balance of devices once they are on the market. This is consistent with the gathering of information from the post-production environment, as referred to in EN ISO 14971:2012, for use in the PMS feedback processes to maintain the safety and performance of medical devices. Additionally, the FDA’s ‘Benefit-Risk Enforcement’ guidance document discusses the consideration of the understanding and management of unanticipated harm and identified device nonconformities in association with their QSR compliance enforcement decisions.

Contact us at to learn about this responsive approach to post-market surveillance.

Larry Mager