Standardizing multi-jurisdictional reporting across FDA, EU MDR, and NMPA using IMDRF codes.
The International Medical Device Regulators Forum (IMDRF) harmonized terms across device problems, health impacts, and root causes. Automated semantic classification tags inbound log files directly with Annex A through G identifiers.
Algorithms assess temporal sequence, dechallenge/rechallenge consistency, and known device risk tables to calculate an objective causality score, assisting clinical safety officers in meeting 5-day urgent reporting requirements.