By Strategic Area
Post-Market Services
For medical device manufacturers with products already on the market that need to generate ongoing clinical evidence and maintain post-market regulatory compliance.
PMCF – Post-Market Clinical Follow-up
We draft the PMCF plan in accordance with the MDR and MDCG guidelines, carry out the planned activities and prepare the PMCF evaluation report, which feeds the clinical evaluation of the device.
Vigilance management
We manage the reporting of incidents and field safety corrective actions (FSCA) under the MDR vigilance system.
Literature and safety signals
We periodically monitor the scientific literature and analyze aggregated safety data, to detect in good time any signals about the device.
People also ask…
No: post-market surveillance (PMS) is the general obligation to collect and analyze post-market data; PMCF is the active clinical follow-up component that generates specific clinical data, required for most medical devices under the MDR.