Tuesday, November 08, 2016 8:45:33 AM
Is the main goal now getting certification for EU? What are the most significant obstacles? What additional work will be required for subsequent FDA clearance? Are we actively working with both agencies at this point?
Is Plexus back to work for us, either directly contracted or through Ximedica?
How many documented procedures are required to prove SPORT's ""task based" functionality versus a predicate device, and how far along are we on that path?
What efforts are being made to enhance SPORT's exposure to the marketplace? Can a recent (not necessarily latest but with basic functionality) device be stored in Europe for more convenient availability for demo use without breaking the budget? What other marketing efforts are underway?
Please post additional ideas... as I mentioned before, I do need to re-work these ideas in such a way as to be "answerable" in the form of a press release, or maybe request a PR strictly for the purpose of status updates.
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