by Innovit Corporate Affairs | Jan 27, 2020 | Blog, MDR
European Commission announced last October that the new EUDAMED will not launch until May 2022, giving everyone enough time to properly prepare for implementing M2M data exchange with EUDAMED. Further, a grace period was also introduced by the EU for certain classes...
by Innovit Corporate Affairs | Nov 25, 2019 | Blog, Eudamed
The European Commission recently announced that the new EUDAMED will not launch until May 2022, even as the MDR takes effect in May 2020. Given this postponement, we now have the opportunity, and sufficient time, to properly prepare for implementing M2M data...
by Innovit Corporate Affairs | Oct 16, 2019 | News
We are so proud to announce that after the initial round of EUDAMED Playground M2M Data Exchange testing, Innovit was the only solution provider able to successfully complete all the test cases for Device/UDI Registration. Those test results were published by the EU...
by Innovit Corporate Affairs | Oct 16, 2019 | Blog, Eudamed
EUDAMED deadlines remain unchanged – the go-live date is still March 26, 2020 with the Date of Application for device registration/submission standing at May 26, 2020. Yet, we’re nearing the end of 2019 with most med device companies still struggling to fully...
by Innovit Corporate Affairs | Jul 18, 2019 | Blog, MDR
Keeping up with the evolving medical device regulation and compliance landscape can be challenging, particularly when technical specifications from the EU Commission are repeatedly delayed. As a global software solution vendor for Life Sciences and Healthcare...