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Originally Posted by Hondaracer
I’m using certification as the medical device term, if you want to get hung up on that go ahead.
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As far as I know regulatory bodies such as FDA and Health Canada do not certify medical devices. They get approved.
Medical devices can be certified by organizations like CSA and UL, but those are not the same.
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I’m basing 44,000 being “small” based on the resulting groups it will be distributed to. I do agree though that the statistical analysis based on this test group will scale to the general population.
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In that case you are not using a evidence based evaluation process. You are basing it on your instinct, which is wrong.