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The 12 Most Important Steps to Global UDI Compliance

The 12 Most Important Steps to Global UDI Compliance

by Ashley Howell | Feb 7, 2023 | Ashley Howell, Blog

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

by Ashley Howell | Feb 1, 2023 | Blog

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...
Onward! A Review of 2022 Meets an Exciting Outlook for 2023 (Part 2)

Onward! A Review of 2022 Meets an Exciting Outlook for 2023 (Part 2)

by Ashley Howell | Jan 23, 2023 | Blog

Welcome back! If you missed our 2022 re-cap in part one of this blog series, you can find it here. If you’re already caught up… Let’s dig into 2023!  We have some exciting announcements that put smiles on our faces! GDSN Multi-Connector:...
Onward! A Review of 2022 Meets an Exciting Outlook for 2023 (Part 2)

Onward! A Review of 2022 Meets an Exciting Outlook for 2023 (Part 1)

by Ashley Howell | Jan 9, 2023 | Blog

We couldn’t be more excited about 2023, but before we move forward, let’s take a look back at all our accomplishments for this year. So, let’s wrap up the incredible, unpredictable and unprecedented year of 2022 through the eyes of achievement! Introducing...
FDA Class I GUDID Compliance Regulation FAQ’s

FDA Class I GUDID Compliance Regulation FAQ’s

by Ashley Howell | Oct 31, 2022 | Ashley Howell, Blog

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 has answers to questions around FDA’s...
9-Steps to GUDID Class I Medical Device Compliance

9-Steps to GUDID Class I Medical Device Compliance

by Ashley Howell | Oct 11, 2022 | Ashley Howell, Blog

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...
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Recent Posts

  • The 12 Most Important Steps to Global UDI Compliance
  • Innovit Client Completes M2M Tests with AusUDID and EUDAMED
  • Onward! A Review of 2022 Meets an Exciting Outlook for 2023 (Part 2)
  • Onward! A Review of 2022 Meets an Exciting Outlook for 2023 (Part 1)

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