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FDA / Health Canada / UK MHRA - Good Machine Learning Practice for Medical Device Development - 10 Guiding Principles (October 27, 2021)

On October 27, 2021 the US Food and Drug Administration jointly with Health Canada and the United Kingdom Medicines and Healthcare products Regulatory…

What FDA / Health Canada / UK MHRA - Good Machine Learning Practice for Medical Device Development - 10 Guiding Principles (October 27, 2021) requires

On October 27, 2021 the US Food and Drug Administration jointly with Health Canada and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) published the Good Machine Learning Practice (GMLP) for Medical Device…

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Pillar: AI Governance & Law · Authority: US FDA, Health Canada, UK MHRA - Good Machine Learning Practice for Medical Device Development Guiding Principles, October 27 2021 · Version: 1.0.0 · Last updated:

Primary source: https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles

SHA-256 integrity: 8cb7aa581c3c6ef4515315bff6e5785e67d7a1d34f6582aa8a0354ff65fa9415

Primary Citations — 12 traced to source

  • FDA, Health Canada, UK MHRA - Good Machine Learning Practice for Medical Device Development Guiding Principles, jointly published October 27, 2021
  • GMLP Principle 1: Multi-disciplinary expertise is leveraged throughout the total product life cycle

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