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Empiricst1

03/28/19 1:40 PM

#259200 RE: frrol #259164

I used to consult for a US company that needed 510-type of equipment approvals in the EU. We would be in the same situation as most small bios re grants -- not likely. The good thing is that the EU now seems to be upping its FDA-type review game, while we have been minimizing ours this last decade or more with misbegotten austerity measures. You get what you pay for, as in the FAA plane crash fiasco. IMO.