by Innovit Corproate Affairs | Sep 8, 2020 | Blog, Eudamed, GUDID
The European Database for Medical Devices (EUDAMED) EU MDR, the European Union’s Medical Device Regulation is intended to support both pre-market product registration processes and post-market surveillance & vigilance activities by national regulators across the...
by Innovit Product Team | Apr 19, 2020 | Blog, GUDID, UDI
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...
by Innovit Corproate Affairs | Sep 24, 2019 | Blog, PIM
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...
by Innovit Corproate 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 Corproate Affairs | Aug 14, 2019 | Blog, GDSN
The goal of UDI is to help improve patient safety by enabling better traceability of medical devices consumed. For the ‘labeler’, UDI will help improve internal processes, bolster master data quality, and provide more accurate reporting and visibility related to...
