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...Healthcare Insights: PIM vs PLM – What’s the Best Method to Address Regulatory Data Submission Challenges?
There’s a mounting list of regulations aimed towards Unique Device Identification (UDI), intended to improve patient safety, supply chain efficiency and post-market surveillance. The benefits are numerous, but challenges continue for medical device suppliers on their...
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...