Core clinical engineering and protocols for Automated PSUR Compilation.
Under Article 86 of the EU MDR, manufacturers of Class IIa, IIb, and III devices must produce a comprehensive Periodic Safety Update Report (PSUR) at least annually. Compiling this report requires aggregating data from hospital complaint logs, field safety notices, customer support tickets, and post-market clinical follow-up studies.
SaMDOps maintains a continuous post-market data warehouse. Complaint records, adverse events, and real-world clinical usage metrics are ingested automatically, statistically aggregated, and rendered into standardized PSUR templates formatted for direct submission to European Notified Bodies and the EUDAMED portal.