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by nradov 751 days ago
Wrong. Merely storing clinical data or providing it to clinicians who use it for diagnostics isn't sufficient for software to be considered an FDA regulated medical device. I have actually built such software and was careful to avoid adding any features that would make it a medical device. Open source software has being used legally by provider organizations for decades.

Instead of remaining ignorant and spreading secondhand misinformation you can literally just go read the federal regulations and supplementary guidance. Or just ask the FDA for a formal opinion letter if you're in a gray area. This is basic stuff, not hard to find or understand.
1 comments
Joel_Mckay 751 days ago
I too have written software for both Canada and the US markets.

Don't YOLO this one kid.

(the fact you didn't mention the 2 other common ISO standards I omitted on purpose, means you have not done your work properly for "years" as you put it.)

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nradov 749 days ago
It's always disappointing to see such ignorance in HN comments like this. While there are some relevant technical standards cross listed with ISO, adherence to ISO standards isn't legally required for products like Metriport. Seriously buddy, you can just go read the FDA regulations instead of making a fool of yourself. But if you'd like to keep looking silly then feel free to have the last word.
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Joel_Mckay 749 days ago
It is ok to disagree kid (I often make mistakes), but asserting your locale's rules are somehow international is a nonsense argument for your own ego.

I would recommend considering programs compatible with your obvious temperament:

https://www.youtube.com/watch?v=XUAsU_zQVMo

Feel free to append any additional off-topic nonsense below if it makes you feel better. I still like you. =3

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