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arnoldb

10/10/15 5:17 AM

#17826 RE: voo #17824

Here is something I posted last week about the CE Mark. I'm fairly confident that the number of participamts in the current trials will be enough for CE


Here is a great presentation of all that is required to get a CE mark for sales in the EU. Most of it has already been done by First Warning System for the iTbra before the change to Cyrcadia. The CE Mark only takes 12 weeks. There is a possibility that it could be issued as early as late March 2016 and sale can begin overseas. That's only 24 weeks from now!


http://www.slideshare.net/emergogroup/getting-ce-marking-for-medical-devices-in-europe