No standards for Medical AI or Machine Learning... (other than IEC 62304 of course).... may we present: Good Machine Learning Practice for Medical Device Development: Guiding Principles
The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). These guiding principles will help promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML).
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