IMDRF · International guidance
IMDRF/AIML WG/N88:2025
Good Machine Learning Practice (GMLP) for Medical Device Development
International Medical Device Regulators ForumIMDRFTechnical guidance
International guidance
This document provides international technical guidance. Publication here does not establish its adoption or binding effect in any national market. Check the applicable national requirements and the issuing authority’s latest publication.
Source identity
- Issuing body
- IMDRF
- Reference
- IMDRF/AIML WG/N88:2025
- Published (source metadata)
- January 29, 2025
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About this guidance
Good Machine Learning Practice (GMLP) for Medical Device Development
Guiding principles for good machine learning practice in medical device development. Addresses AI/ML lifecycle, data quality, and validation.