Clinical Informatics

What is SaMD?

Software as a Medical Device. Software that meets regulatory criteria as a medical device, including some CDS.

meets device criteria · regulated

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In real work

Legal asked whether the new triage model counted as SaMD before go-live.

In the illustration

Three software cartridges run through the gauge; two pass to the general lane, and the triage model trips the criteria fingers into the device lane, which gets a review tag.

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