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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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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.
How many controls does IMDRF N88 Good Machine Learning Practice for Medical Device Development: Guiding Principles (2025) have?
IMDRF N88 Good Machine Learning Practice for Medical Device Development: Guiding Principles (2025) contains 10 controls organized across 1 domains.
Where does IMDRF N88 Good Machine Learning Practice for Medical Device Development: Guiding Principles (2025) apply?
IMDRF N88 Good Machine Learning Practice for Medical Device Development: Guiding Principles (2025) applies in International. Organizations operating in or serving customers in this jurisdiction should check whether its requirements reach them.
Which version of IMDRF N88 Good Machine Learning Practice for Medical Device Development: Guiding Principles (2025) is covered here?
This page covers IMDRF/AIML WG/N88 FINAL:2025 (27 January 2025).

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IMDRF N88 Good Machine Learning Practice for Medical Device Development: Guiding Principles (2025), its 10 controls and every mapping into other standards are available over a REST endpoint and an MCP server, so an agent can read them directly. The free tier is 10 calls a day and needs no signup.

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Written and maintained by Gerard Blokdyk, The Art of Service.Last updated .