IMDRF N88 Good Machine Learning Practice for Medical Device Development: Guiding Principles (2025)
Section 3: Guiding principles – IMDRF N88 Good Machine Learning Practice for Medical Device Development: Guiding Principles (2025)

IMDRF N88 Good Machine Learning Practice for Medical Device Development: Guiding Principles (2025) P1: Understand the intended use deeply and bring multi-disciplinary expertise across the life cycle

What does P1 require?

The manufacturer builds an in-depth understanding of the device's intended use and intended purpose, including where it sits in the clinical workflow and the benefits sought and patient risks involved, so that the AI-enabled device meets a clinically meaningful need throughout its life; expertise from several disciplines supplies the context, shapes the intended use and improves safety and effectiveness.

Maintained by Gerard Blokdyk

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