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FDA Class I GUDID Compliance Regulation FAQ’s

FDA Class I GUDID Compliance Regulation FAQ’s

by Innovit Corporate Affairs | Oct 31, 2022 | Blog, GUDID

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 Innovit Corporate Affairs | Oct 11, 2022 | Blog, GUDID, Michelle Laurion

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...
Democratizing MDM

Democratizing MDM

by Innovit Corporate Affairs | Oct 4, 2022 | Michelle Laurion, Videos

In a global, data-driven and digital world, standardizing, mastering and leveraging high volumes of master data in an automated process is a strategic and business...
Key Insights from Early EUDAMED Testing

Key Insights from Early EUDAMED Testing

by Innovit Corporate Affairs | Oct 4, 2022 | Videos

Key Insights from Early EUDAMED Testing & Post Go-Live Feedback Webinar   Lorem ipsum dolor sit amet, consectetur adipiscing elit. Fusce volutpat rhoncus consectetur. Proin sed blandit arcu. Duis scelerisque justo sit amet dui posuere...
Innovit & 1WorldSync: “The Arthrex Journey”

Innovit & 1WorldSync: “The Arthrex Journey”

by Innovit Corporate Affairs | Oct 4, 2022 | Videos

Innovit & 1WorldSync: “The Arthrex Journey” Achieving Data Requirements for UDI   Innovit and 1WorldSync experts discuss the Arthrex Journey” Achieving Data Requirements for UDI & Beyond and the delivery of a PIM Lite...
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Recent Posts

  • EUDAMED Go-Live Announcement: Streamlined UDI Data Submission using Innovit EUDAMED Connector
  • Updated Timeline: Mandatory Use by Q4 2025 – Current planning for gradual roll out and modules’ functionality view
  • MDR Third Amendment is official: EUDAMED Mandatory Use by January 2026
  • TGA’s Australian UDI Database: Deadline Update

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