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That's a real surprise. I was under the impression that medical equipment was incredibly difficult to get approved for use.
by levythe 7y ago
That's a real surprise. I was under the impression that medical equipment was incredibly difficult to get approved for use.
- rusk 7y agoA common misconception https://www.youtube.com/watch?v=-tIdzNlExrw https://www.youtube.com/watch?v=-tIdzNlExrw
- thefounder 7y agoIn Europe is easier to get approved but this is changing...
- bilbo0s 7y agoWell, in the US, there's the FDA. And that is a bit more stringent than EU. But even in the US, medical equipment breaks down. Just not at near as high a rate.
- rusk 7y agoFDA has faaar less stringent regulations for medical equipment than for drugs.
- bilbo0s 7y agoLess stringent is not the same as not stringent. I made medical imaging software for diagnosis and analysis. We would get a regulatory proctology exam every release. These guys would find arithmetic errors in papers referenced to support algorithms used in the software, and ask us about them. (Incidentally, that's where I learned never to trust "peer reviewed" papers or dissertations in computer science. Always check it, in detail, yourself. CS guys have to be some of the worst mathematicians I've seen during my time in scientific research.) But yeah, the FDA were that anal in our case. If they were not that anal for you, I'm not sure why that is? Maybe the radiation? We were putting out software that potentially dealt with, essentially, irradiating humans. Software that controlled radioactive devices. Etc. No one wants the equivalent of a dirty bomb going off in some small town somewhere. So I don't blame the FDA for the whole "every i dotted, every t crossed" treatment. It was actually reassuring. At least in our case.