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What is the best path for UDI compliance? Examining Two Approaches for Medical Device Suppliers

by Innovit Corporate Affairs | Jul 24, 2019 | Blog, UDI

As a global software solution vendor in Life Sciences & Healthcare, our customers include many of the top medical device suppliers managing high volumes of product data and tens of thousands of device records.  Based upon our experience helping customers with...

FDA’s GUDID Medical Device Data Corrections – Implications of the Shortened Grace Period

by Innovit Corporate Affairs | Jun 3, 2019 | Blog, GUDID

In 2014, the seven-day grace period for Global Unique Device Identification Database (GUDID) submission corrections was extended to 30 days.  Over time, healthcare providers provided feedback stating that 30 days is too long to wait for access to “key...

The Latest UDI News: Convenience Kits Q&A from the FDA

by Innovit Corporate Affairs | May 21, 2019 | Blog, UDI

Recently, the FDA issued the final guidance, “Unique Device Identification: Convenience Kits” to help clarify the FDA’s policy related to UDI considerations for medical procedure kits. The intent of this guidance is to ensure that the exception for UDI labeling of...
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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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