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...
Introducing MDM.Cloud
We’re excited to introduce you to Innovit’s next-generation solution, MDM.cloud for the Australian market! Current iICE Validator customers can take advantage of our MDM.cloud system upgrade NOW! MDM.cloud for NPC was initially created for the National Product...
Device Registration ‘is live’ for voluntary UDI data submission
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...
Q&A: Is GDSN a Viable Option to Submit Data to EUDAMED?
EUDAMED timelines are quickly approaching, and UDI data preparation is no easy task. Preparing early with a master data strategy will make all the difference when mandates for EUDAMED and other health authorities come due. A large component of that strategy centres...
EUDAMED Implementation and Roll-Out Timeline Update
The European Commission recently sent out an update on the plan for implementation and roll-out of EUDAMED, as it stands today. Changes to the implementation timeline of different modules, and how they will affect the application of each aspect of MDR are outlined...