Hardware Podcasts

#357: The State of UDI Across the World

Global Medical Device Podcast · 7 Mar 2024 · 52m · Episode 357

What this episode covers

Gary Saner, a UDI expert and co-chair of the industry's structured product labeling technical team, discusses the evolving global landscape of Unique Device Identification (UDI) compliance with host Etienne Nichols. Saner highlights critical upcoming deadlines in the European Union, specifically the potential 2025 mandatory reporting window, and contrasts these with the simpler, US-aligned implementation in Australia. He outlines common pitfalls such as data cleansing, deprecated nomenclature, and the failure to build scalable, global systems, while recommending early engagement with technology solutions like ReedTech to manage complex regulatory requirements.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Greenlight Guru, ReedTech
Also
UDI-MED, TGA, GMDN, HL7

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