FAQ: Global Unique Device Identification Database (GUDID)

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...

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...

FREE Early Access to the EUDAMED Test Environment!

Innovit is Excited to Announce Our EUDAMED.cloud Test Environment! To the best of our knowledge, we are the only company offering free access to a EUDAMED testing environment for all medical device manufacturers – helping you stay ahead of the curve for EUDAMED...
EUDAMED Implementation and Roll-Out Timeline Update

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...
Q&A: Is GDSN a Viable Option to Submit Data to EUDAMED?

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...