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
ISO 13485 & AI
ISO 13485 is the international standard for quality management systems for medical devices.
For AI medical-device manufacturers, the key question is:
How do we apply a medical-device QMS to AI development and lifecycle management?
Relevant areas include:
- Design and development controls
- Documentation
- Risk-based processes
- Supplier controls
- Verification and validation
- Production and deployment
- Change control
- Complaint handling
- CAPA
- Post-market surveillance
- Traceability
For AI, companies need to integrate these processes with controls around:
- Data
- Algorithms
- Training
- Validation
- Model changes
- Software updates