GUDID and UDI – Are You Prepared?

GUDID and UDI – Are You Prepared?

The Global Unique Device Identification Database (GUDID) is a database administered by the FDA that will serve as a reference catalog for every medical device with an identifier.  Unique Device Identification (UDI) is a system to mark and identify medical devices (via...

EUDAMED – Deadlines Updated

The  European Commission recently announced  that the new EUDAMED will not launch until May 2022, even as the MDR takes effect in May 2020.  Given this postponement, we now have the opportunity, and sufficient time, to properly prepare for implementing M2M data...
Is PTC Windchill Exiting the UDI Compliance Market?

Is PTC Windchill Exiting the UDI Compliance Market?

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...