Hardware Podcasts

UDI and the Current State of Global Implementation

Global Medical Device Podcast · 18 Aug 2022 · 45m · Episode 276

What this episode covers

Gary Saner, Senior Manager of Information Solutions at Reed Tech, discusses the complexities of Unique Device Identification (UDI) implementation in the US and EU. He details the FDA's Class I UDI deadlines, the four quadrants of compliance, and the data challenges of submitting to GUDID. Saner contrasts this with the EU's MDR/IVDR overhaul, explaining the EUDAMED database, the 'Basic UDI-DI' concept, and the lack of global harmonization.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Green Light Guru, Reed Tech, FDA
Also
GUDID, EUDAMED, EMDN

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