Structured control of algorithm updates and retraining, plus integration of an ISO/IEC 42001 AI management system alongside your existing ISO 13485 QMS.
What this covers
Control of algorithm changes, updates, and retraining processes
Validation and revalidation requirements for model updates
Performance monitoring and drift detection mechanisms
Integration of ISO/IEC 42001 AI management system within the medical device QMS
Traceability between model versions, training data, and outputs
AI-specific policy, control, and accountability structures
When this is typically needed
Deployment of adaptive or continuously learning algorithms
Frequent model updates impacting device performance or safety
Implementing an AI management system alongside a medical device QMS
Post-market monitoring of AI performance and reliability