Glossary · Regulation
IMDRF
International Medical Device Regulators Forum
IMDRF is a voluntary group of medical device regulators, including the EU, US, Japan, China, Canada and others, with WHO as an observer, that writes harmonised guidance for regulators.
Its documents defined the term software as a medical device and its risk categories, and its machine learning principles are adopted or adapted by member regulators.
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Definitions written by Anpheros from the official sources linked on each page. General information about standards and regulation, not legal or medical advice. All terms →