Integrating Artificial Intelligence (AI) and Machine Learning (ML) into medical devices and SaMD unlocks major clinical value—while raising regulatory scrutiny around safety, reproducibility, and clinical evidence.
AI-enabled medical products are regulated under EU MDR or IVDR (alongside emerging EU AI Act requirements and FDA PCCP/AI guidance), requiring solid documentation across:
- Representative training/test dataset governance and bias mitigation
- Clinical performance metrics and independent validation strategies
- Explainability, human oversight, and usability engineering (IEC 62366-1)
- Cybersecurity and IEC 62304 software lifecycle control
- Continuous post-market performance monitoring for model drift
Glaze Medical helps you define your regulatory pathway, conduct gap analyses, structure your Technical File, and engage effectively with Notified Bodies—bringing medical AI safely and efficiently to market. Contact us to discuss your AI product.