Replies to post #137 on Endra Life Sciences Inc (NDRA)

[apollo1452]

Successful completion of the Robarts feasibility study for TAEUS means filing for Euro CE Mark is on deck.

"I would say almost immediately after we receive the CE Mark approval, we think we’ll have systems in the hands of our first round of adopters" CEO Michelon on last CC.

NDRA already has a list of over 500 medical professionals who are interested in TAEUS, they will be the "early adopters".

Euro CE Mark requires proof of the "Safety" of a medical device usage. FDA 510K approval requires requires proof of "Safety & Efficacy".

NDRA has ALREADY achieved the key milestone needed for Euro CE Mark approval & now the Robarts feasibility study is done.

On 4/3/19 NDRA received Medical Device Quality Management System ISO Certification Number MD 697226 from British Standards Institution (BSI).

Companies operating outside the Euro market that already have a Quality Management System founded on ISO 13485 (like NDRA) CAN MORE EASILY OBTAIN THE EURO CE MARK FOR THEIR PRODUCTS, as many of the requirements are already met.