meddev-ai-ml-medical-device-software
Address machine learning inside the regulated product (not LLM coding assistants): Good Machine Learning Practice (GMLP), training/validation data integrity, Predetermined Change Control Plans (PCCP) where applicable, drift monitoring, and linking models to ISO 14971 and software lifecycle controls. Use when working on ai ml medical device software in medical device software.
- Version
- 1.0.0
- License
- MIT
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