Patient Safety Event Review overview

Reviews reported patient safety events and adverse incidents -- triaging incoming event reports by severity classification, conducting root-cause analysis with clinical and engineering teams, correlating device telemetry or software logs with patient outcomes, evaluating whether corrective action is required, and filing regulatory reports (FDA MedWatch, MHRA Yellow Card) within mandated timelines. Produces incident investigation reports, corrective action plans, and regulatory submission records. Excludes clinical treatment decisions.