PMS & Risk Management in EU MDR

With May 2021 deadline approaching, central focus for all companies should be post market surveillance (PMS) and its related processes and subsystems.

The thread of risk management connects every piece in the quality management system (QMS) and guides the manufacturer in quality related decision-making throughout the life cycle of the device.

The PMS data collection and analysis processes can directly interface with the organizational processes as defined per ISO 14971. In EU MDR, it is important to understand responsibility of PMS function as a partner to risk management function. An efficient interface between PMS and risk management will help in conversion of PMS data and information into easily usable knowledge for the risk management function.