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 | Sep 24, 2019 | Blog, PIM
There’s a mounting list of regulations aimed towards Unique Device Identification (UDI), intended to improve patient safety, supply chain efficiency and post-market surveillance. The benefits are numerous, but challenges continue for medical device suppliers on their...
by Innovit Corporate Affairs | Sep 19, 2019 | Blog, UDI
If you’re a medical device manufacturer or supplier submitting data to the FDA’s GUDID system, then your life may be getting a bit more complicated if you’re also using PTC’s UDI solution to comply with this FDA regulation. Recent announcements suggest that PTC is...
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...
by Innovit Corporate Affairs | Jul 15, 2019 | Blog, Eudamed
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 members of MedTech Europe and Healthcare Transformation Group, we’re doing...