Is GHX Discontinuing Support for GUDID and EUDAMED?

by | Jan 8, 2020 | Blog

In September 2019, we witnessed PLM software giant, PTC Windchill, quietly exit the UDI compliance market.  As we ended 2019, several little birds have shared that GHX is slated to phase out support for their UDI Data Submission Service and will not be providing a...
Is PTC Windchill Exiting the UDI Compliance Market?

Is PTC Windchill Exiting the UDI Compliance Market?

by | Sep 19, 2019 | Blog

If you’re a medical device manufacturer or supplier submitting data to the FDA’s GUDID system, then your life may be getting a bit more complicated if you’re also using PTC’s UDI solution to comply with this FDA regulation.  Recent announcements suggest that PTC is...

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

by | May 21, 2019 | Blog

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...