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 catalogue for every medical device with an identifier.  Unique Device Identification (UDI) is a system to mark and identify medical devices...

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EUDAMED and MDR: Readiness Tips

With a March 2020 go-live date, The European Database for Medical Devices (EUDAMED) will be open to many more groups, including manufacturers, importers and sponsors.  Current estimates are that this covers 70,000+ individual organisations and over 300,000 actual...

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