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 Regulatory Compliance
This is the broader regulatory framework governing AI-enabled medical products.
It addresses how companies demonstrate that their AI product complies with applicable regulatory, quality, safety, cybersecurity, privacy, and clinical requirements.
The compliance lifecycle can be presented as:
AI Concept → Intended Use → Classification → Risk Assessment → Development → Validation → Regulatory Submission → Approval → Deployment → Post-Market Monitoring
Topics can include:
- Regulatory strategy for AI/ML products
- Medical-device regulations
- Software as a medical device
- Clinical evaluation
- AI validation
- Change management
- Cybersecurity
- Data governance
- Privacy
- Post-market surveillance
- Regulatory submissions
- Documentation requirements