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
AI Complaint Handling & Vigilance
What it means:
This topic focuses on how manufacturers identify, investigate, document, and report complaints involving AI-enabled medical devices.
AI devices create some unique complaint scenarios. For example:
- AI gives an incorrect diagnosis or recommendation.
- The algorithm produces inconsistent results.
- Model performance decreases after deployment.
- A software update changes clinical performance.
- Bias causes poorer performance for a particular patient population.
- The device generates an incorrect alert or fails to generate an expected alert.