Hardware Podcasts

Understanding the UDI System for Medical Devices

Global Medical Device Podcast · 6 Jan 2022 · 34m · Episode 241

What this episode covers

Mark Rutkiewicz, VP of Quality at Innovize and founder of Consiliso, explains the Unique Device Identification (UDI) system for medical devices, emphasizing its role in patient safety and post-market surveillance. He details the choice between GS1 and HIBC identifiers, the technical differences between Data Matrix and QR codes, and the complexities of integrating UDI data into FDA and EU databases. Rutkiewicz also discusses the challenges of labeling tiny or implantable devices and the lack of industry-standard label templates.

Most relevant to

established companies

Topics

Mentioned

Companies
Innovize, Consiliso, MDIC, Greenlight Guru
Also
GS1, HIBC, FDA

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