Start your Class I FDA GUDID data submission journey with these initial steps!
It’s hard to believe we’re more than halfway through January! You should be thinking and planning for the FDA’s GUDID compliance deadline for Class I medical devices. September 24, 2022 is just around the corner! Time certainly flies – and even with the...Introducing Innovit’s EUDAMED Reference Center
As a medical device provider one of the biggest changes on the horizon will be the new EU requirements for product information, as well as the FDA’s GUDID compliance deadline for Class I medical devices. Even the most experienced companies uncover critical gaps in...
Device Registration ‘is live’ for voluntary UDI data submission on EUDAMED
Last week, the European Commission announced the successful launch of its EUDAMED “Device Registration” and “NBs & Certificate” modules (Production release “v2.0 – September version” was deployed). The EUDAMED UDI/Device Registration and NBs &...