Algorithm Change & Performance Controls

What This Service Covers

Control of algorithm changes, updates, and retraining processes
Validation and revalidation requirements for model updates
Performance monitoring and drift detection mechanisms
Integration of algorithm changes with risk management and CAPA
Establishment of traceability between model versions, data, and outputs

When This Service Is Typically Required

Deployment of adaptive or continuously learning algorithms
Frequent model updates impacting device performance or safety
Regulatory requirements for controlled algorithm modification
Post-market monitoring of AI performance and reliability

Applicable Regulations & Standards

ISO 13485
ISO 14971
IEC 62304
ISO/IEC 42001
FDA and EU guidance on AI/ML lifecycle management

How This Fits Within the Quality System

Algorithm changes and performance monitoring are controlled through QMS processes, ensuring that updates are evaluated, validated, and documented within the same system governing design, risk, and post-market activities.

Contact

Engage with us to establish controlled and compliant management of algorithm changes and performance across the product lifecycle.