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Comment by loorke

6 hours ago

> two of them (HIPPA and FDA approvals) are American

I specified all three via comma to highlight that we had quite some history in compliance, in different jurisdictions.

HIPPA covers only medical devices, GDPR covers everything. FDA approval process is convoluted and expensive, especially for new types of devices, but it's still much easier than European MDR.

Also, I mentioned FDA because we didn't even try to get a proper compliance in the EU, because it's impossible for a startup without huge support.