Automating continuous real-world clinical data pipelines to satisfy EU MDR Periodic Safety Update Reports (PSUR).
Under EU MDR Article 87, manufacturers must collect proactive clinical performance data throughout device lifetime. The platform continuously aggregates telemetry to feed Periodic Safety Update Reports (PSUR) and Summary of Safety and Clinical Performance (SSCP).
As EUDAMED becomes mandatory across Europe, our data schema maintains native compatibility with European Commission XML structures for Serious Incidents (MIR - Manufacturer Incident Report Form).