Glossary
Post-Market Surveillance
Also called: PMS
Monitoring a device's real-world performance after authorization, which for adaptive AI is where most of the meaningful evidence has to come from.
Post-market surveillance covers adverse event reporting, performance monitoring, and corrective action after a device reaches market. For AI devices cleared on retrospective data, it is where real-world performance is actually established.
Where This Gets Misread
Surveillance depends on someone noticing and reporting a problem, and AI failure modes are unusually quiet. A model that gradually degrades on a new scanner produces no alarm, no error, and no obvious event to report. Absence of adverse event reports is weak evidence of safety here.