# UDI: 101

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-01-21
- Length: 33m
- Episode: 302
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-21-udi-101
- Listen: https://podcast.greenlight.guru/episode/udi-101

## Summary

Brittani Smith and Laura Maher, Medical Device Gurus at Greenlight Guru, explain the implementation of Unique Device Identifiers (UDI) for medical devices. They detail the structure of the UDI (Device Identifier and Product Identifier), the use of leading zeros for packaging levels, and the critical importance of barcode verification standards like IEC 15434. The guests also discuss the process of registering devices in the FDA's GUDID database and the safety benefits of UDI for traceability in clinical settings.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-21-udi-101#t=0) Introduction and Guest Backgrounds
- [6:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-21-udi-101#t=414) UDI Structure: DI and PI
- [8:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-21-udi-101#t=484) Packaging Levels and Leading Zeros
- [14:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-21-udi-101#t=862) Barcode Verification and Quality Standards
- [12:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-21-udi-101#t=720) GUDID Registration and Process Flow
- [21:09](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-21-udi-101#t=1269) Safety Benefits and Clinical Traceability
- [25:14](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-21-udi-101#t=1514) Resources and Final Advice

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)

## Most relevant to

established companies

## Mentioned

- Greenlight Guru (company)
- GS1 (other)
- GUDID (other)
- ReTech (company)
- FDA (other)

## Related episodes from other shows

- [054 - "EUDAMED" with Richard Houlihan](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-12-054-eudamed-with-richard-houlihan) (Let's Combinate)
- [S1E12 Simplifying Quality Management | Jon Speer](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer) (Being an Engineer)
- [077 - 8 Databases and How To Use Them with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-22-077-8-databases-and-how-to-use-them-with-michelle-lott) (Let's Combinate)
- [094 - Connected Combination Products, Product Traceability, Regulating New Products, Pre-Determined Changes and AI/ML with Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-19-094-connected-combination-products-product-traceability-regulating-new-products) (Let's Combinate)
- [70 - Charlie Webb from Van Der Stahl Scientific](https://hardwarepodcasts.com/podcast/people-of-packaging/2021-08-19-70-charlie-webb-from-van-der-stahl-scientific) (People of Packaging)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-21-udi-101. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.