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Good Machine Learning Practice for Medical Device Development: MHRA, FDA and Health Canada Guiding Principles
The U.S. Food and Drug Administration (FDA), Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified 10 guiding principles for Good Machine Learning Practice (GMLP) in medical device development. These principles aim to support the development of safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML). They address the unique challenges associated with data-driven de
Sharan Murugan
1 hour ago4 min read
IMDRF Med Dev Guidance: Good Machine Learning Practice (GMLP) for Medical Device Development: IMDRF’s Guiding Principles
The International Medical Device Regulators Forum (IMDRF) has released its final guidance document (IMDRF/AIML WG/N88:2025) outlining...
Sharan Murugan
Feb 1, 20253 min read