Health tech
Software as a medical device
Software that is itself a medical device because its intended purpose is medical, such as diagnosing, monitoring or treating a condition. It must meet medical device regulations. Often shortened to SaMD.
A plain-English explanation of industry terms, not medical, legal or regulatory advice. Disclaimer.
You'll hear it as
Adding risk scores turned our app into software as a medical device.
Why it matters to you.
What you claim the software does decides whether it's regulated. Marketing copy can change your regulatory status.
Also called SaMD.
Related terms.
Videos.
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