IMDRF N88 Good Machine Learning Practice for Medical Device Development: Guiding Principles (2025)
What is IMDRF N88 Good Machine Learning Practice for Medical Device Development: Guiding Principles (2025)?
The IMDRF's ten guiding principles for good machine learning practice in medical devices: intended use and multi-disciplinary expertise, engineering and security fundamentals, representative and independent datasets, fit-for-purpose reference standards, suitable model design, human-AI team assessment, clinically relevant testing, clear user information, and post-deployment monitoring and re-training controls. It comprises 10 controls organised across 1 domains, and applies in International.
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