The 12 Most Important Steps to Global UDI Compliance

The Staggering Number of Global UDI Requirements Demand Immediate Action in 2023  The importance of accurately managing product data is evident in healthcare. After all, most of these products have a direct impact on people’s health: Things like heart valves,...
Innovit Client Completes M2M Tests with AusUDID and EUDAMED

Innovit Client Completes M2M Tests with AusUDID and EUDAMED

With Innovit’s expertise, our client achieved all goals and completed M2M tests with AusUDID and EUDAMED Innovit is proud to announce that one of our clients, a global medical device company and leader in orthopedic devices, was the first to complete M2M testing with...
FDA Class I GUDID Compliance Regulation FAQ’s

FDA Class I GUDID Compliance Regulation FAQ’s

GUDID Compliance Regulation FAQ’s We held a webinar last week titled, ‘9-Steps to GUDID Class I Medical Device Compliance’ and received a number of great questions from our attendees.  We thought it’d be helpful to put these FAQs in a blog and ensure everyone...
9-Steps to GUDID Class I Medical Device Compliance

9-Steps to GUDID Class I Medical Device Compliance

On July 22, the FDA posted its final guidance regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products. The FDA will enforce the GUDID submission requirements for Class I and...