We integrate AI/ML-specific design controls into an existing medical device QMS so that AI-enabled products (including AI SaMD and AI components embedded in hardware systems) are developed, verified and validated, released, and maintained in compliance with FDA 21 CFR 820 (and the QMSR transition principles) and ISO 13485, while remaining scalable for iterative model updates.
Purpose: Make AI design controls inspection-ready.
Deliverables:
- AI-specific Design History File (DHF)
- Training/test dataset governance SOPs
- Bias, fairness, and representativeness controls
- Software V&V framework (AI-specific)
- Traceability matrix (requirements → model → clinical claims)
Duration: 6–10 weeks
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