Announcing Innovit’s 2022 Event Calendar
As we look ahead with optimism to traveling again in the coming year, with some expected bumps along the way, we’re thrilled to share Innovit’s return to in-person events in 2022! No doubt we’ve all gained some new appreciation for ‘real’ in-person events – so we...
FAQ: Global Unique Device Identification Database (GUDID)
What is GUDID? GUDID is an acronym for the Global Unique Device Identification Database — a central repository of detailed medical device information created by the US FDA. It is often pronounced “Good ID”. The GUDID system was implemented as a component of the...
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...
Innovit’s 2021 Recap and a Look Ahead!
2022 is almost here and the holiday season is in full flight! As another turbulent year comes to an end, the team at Innovit took a moment to reflect on the past year while also looking ahead with zeal and optimism. Though agility and adaptability are nothing new...
Your New Year’s Resolution! Five easy steps for Risk Class I data submissions to FDA GUDID!
With the New Year almost upon us, the FDA's GUDID compliance deadline for Class I medical devices must now be met with urgency. September 24, 2022 is just around the corner! In an effort to help the industry remain focused on COVID-19 response efforts, while still...
Gain market insight & a deeper understanding of EUDAMED requirements. Join the EUDAMED Leadership Council!
Innovit is excited to announce the formation of a EUDAMED Leadership Council Group on LinkedIn which includes participants from a number of leading medical device manufacturers including Arthrex, B. Braun, Bio-Rad, Medtronic, 3M, Molnlycke, Ascensia Diabetes. The...
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 & Certificates...
Webinar: Key Insights from Innovit’s Early EUDAMED Testing & Post Go-Live Feedback
The ever-changing EUDAMED compliance landscape has been flushed with uncertainty. And, although the deadline delays may have come as a welcomed relief to some organizations, the mandate to comply is inevitable! As one of the few vendors granted early access to the...
Tackling the Transition of GHX from UDI & EUDAMED Compliance at the Same Time
GHX, a GDSN data pool and EDI solution provider, will phase out support for their GUDID Submission Service by December 2021, and do not have plans to provide a EUDAMED compliance solution. If you’re a medical device labeler submitting device data to the GUDID via...