by Innovit Corporate Affairs | Jan 8, 2020 | Blog, Eudamed, GUDID
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...
by Innovit Corporate Affairs | Oct 17, 2019 | Blog, GUDID
The beginning of July brought several major announcements in the product content and data synchronization market. The joint venture between GS1 Germany and GS1 US effectively ended with the demerger from 1WorldSync, which has evolved as follows: Battery Ventures, a...
by Innovit Corporate Affairs | Sep 19, 2019 | Blog, UDI
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...
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...
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...
