I agree Gekkowolf,
The company will challenge these findings from a few selected oversight committee.
Lets see what comes of the challenge. I think the company needs to get together with BSI and discuss all the information/results and determine what went wrong with the review by the oversight committee. Maybe they didnt quite understand the data - maybe they were under the impression that the device was meant to show superior results on its own - however that is NOT what the trial was about. Somethings has gone wrong in translation.
I am hoping today's monumental set back is corrected over the coming weeks. Very keen to hear back from the company once they have their meeting with the BSI Body on the path forward.
Ann: CE Marking Update, page-53
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