Cabe,
How is this anything but positive news? Stage 2 Audit completion could be as short at 1 month, which having had a predicate device already approved with CE mark may be the case. The path to market has some key steps to it and those steps are being achieved. Whether it's 3 months - 6 months one would suggest that if those steps are critical to a highly successful launch and acceptance by the medical community, then they should be conducted at the highest standard, with the utmost rigour to ensure the very best product/platform, supported by the best people is going out to the users who need it.
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Cabe,How is this anything but positive news? Stage 2 Audit...
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