Connect risk management to PMS and GSPR
Use risk outputs across surveillance, clinical evaluation, and requirements traceability.
Complya does not operate a PMS feed or a live risk register. This article describes the connections the manufacturer's controlled processes and documents should maintain.
Risk management should inform PMS and PMCF plans. Residual risks, uncertain controls, complaint trends, and clinical uncertainties are natural inputs for post-market monitoring.
The risk file should also support GSPR traceability. Safety and performance requirements often rely on risk controls, verification evidence, labelling, and clinical conclusions.
When post-market data reveals a new signal, feed it back into the risk file and related documents. A living risk process is easier to defend than a file that stops at launch.
This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.
European Commission — Medical Devices: New regulationsRegulation (EU) 2017/745 — Medical Device RegulationRegulation (EU) 2017/746 — In Vitro Diagnostic Medical Devices