Use complaints, feedback, sales, and service data

Post-market surveillance is strongest when routine data is collected consistently. Complaints, customer feedback, repairs, returns, service records, training issues, and sales volumes can all help interpret safety and performance signals.

Define how data will be normalized and trended. A raw complaint count may be misleading without denominator information such as units sold, active users, procedures, tests, or exposure time.

Escalation rules matter. The PMS process should explain when signals trigger CAPA, vigilance assessment, risk-file updates, clinical evaluation updates, or expert review.