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by tsbischof 1834 days ago
Independent verification is not always performed for 510k submissions, but yes that would be ideal
1 comments

it's great that you asked about clinical trials. we conducted them blindly, with the participation of several doctors. the device measured the mole, and then it was examined by a doctor. after that, a biopsy and histology were performed. these data were compared. now this data is unstructured and the histology documents contain personal data of people. but I will soon process everything and also post it on the site. I didn't think it was interesting. everyone needs FDA and 510k certificates