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Comment by bizzleDawg

3 days ago

I came here to say the same as the parent comment - it's an amazing achievement, but you may well have built a medical device which needs certification in order to be on the market in the territories you want to use it in.

I work (freelance) with a consultancy [1] that helps specifically with software-as-a-medical-device (SaMD). My email is in my profile if you want to chat about what might be the best way forward.

[1]: https://www.hardianhealth.com/