Post-Market Surveillance
Automated trend detection that feeds signals straight back into your risk file.
Continuously scans your complaints and nonconformances for trends — clusters and spikes by product, lot, and severity measured against a prior equal window — and surfaces them as signals for review. Dispositioning a signal raises a risk-review flag on the linked risk file, closing the post-market → risk loop so a real-world signal actually reaches the risk analysis instead of sitting in a spreadsheet.
Signals are computed deterministically — the same data always yields the same trends, so it's reproducible for an auditor, not a black box. Nothing auto-changes a record: a human dispositions each signal, and that disposition (and the risk-review flag it raises) is written to the immutable, hash-chained audit trail.
- ✓ Automated trend detection across complaints and nonconformances
- ✓ Clusters and spikes by product, lot, and severity vs. a prior window
- ✓ Deterministic, reproducible signals — auditable, not a black box
- ✓ Disposition a signal to raise a risk-review flag on the risk file (post-market → risk loop)
- ✓ Every signal disposition on the immutable audit trail
- ✓ A post-market surveillance plan for each device (ISO 14971 §10), written through a guided interview and approved with an e-signature by someone other than its author