Facetrain, very informative posts! Thank you not only for today's input, but prior posts as well (which I pasted links below for those interested in catching back up - worthwhile reading for Titan aficionados!).
Despite your European locale, you seem to have a better grasp of FDA requirements than most folks here in the US! Your insights are appreciated.
Message in reply to: For those who are not familiar with the CE Route. Titan in 2019 has implemented a Quality system according to ISO 13485. 28 Countries i.e. EU, Canada, Japan und Australia have recognized ISO 13485 however the USA still requests the FDA Quality System Regulation (QSR). ISO 13485 and (QSR) differ in many important aspects.
Due to the encouriging statements by Martha today it is very unlikely that MDT will not utilize the CE route first. If the validation of the Sport Hard- and Software is finalized in 2020, market entry in Europe is feasible in Europe second quarter 2021. However more likely in India since MDT currently is creating its second largest R+D Center worldwide in India.
This szenario is in particular more likely since the new Medical device regulation (MDR), coming up with by far tighter preconditions, was postponed until May 2021. For the time being every device maker is hurrying to match this timeline. Thanks Facetrain
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