4th International Conference on
AI in Healthcare, Industry & Regulatory Affairs
May 25–27, 2027 | Toronto, Canada
Four Points by Sheraton Toronto Hotel
Address: Mississauga, 6090 Dixie Road, Mississauga, ON, L5T 1A6, Canada
AIHIRA 2027
CAPA for AI Medical Devices
CAPA = Corrective and Preventive Action.
For AI medical devices, CAPA goes beyond fixing a traditional hardware or software defect. A manufacturer may need to determine whether the problem originates from:
Data → Model → Software → User → Deployment Environment → Update → Monitoring
For example, if an AI diagnostic system starts producing more false negatives, the CAPA investigation may examine:
- Training data
- Validation data
- Algorithm performance
- Data drift
- Model updates
- Software changes
- Integration problems
- User workflow
- Cybersecurity issues