Post-Market Surveillance (PMS) is the systematic process of monitoring an AI medical device after it has been placed on the market to ensure that it continues to be safe, effective, reliable, and compliant.
For AI medical devices, PMS is especially important because an AI model can behave differently in the real-world environment than it did during development and clinical validation.
What should be monitored?
1. AI Performance
2. Model Drift
3. Complaints & Incident
4. CAPA & Corrective Action
5. AI Model Updates