# Understanding the UDI System for Medical Devices

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-01-06
- Length: 34m
- Episode: 241
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-06-understanding-the-udi-system-for-medical-devices
- Listen: https://podcast.greenlight.guru/episode/understanding-the-udi-system-for-medical-devices

## Summary

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.

## Chapters

- [0:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-06-understanding-the-udi-system-for-medical-devices#t=21) Introduction: Mark Rutkiewicz and Consiliso
- [4:19](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-06-understanding-the-udi-system-for-medical-devices#t=259) The Purpose and History of UDI
- [7:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-06-understanding-the-udi-system-for-medical-devices#t=470) GS1 vs. HIBC Identifiers
- [10:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-06-understanding-the-udi-system-for-medical-devices#t=631) Data Matrix vs. QR Codes
- [13:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-06-understanding-the-udi-system-for-medical-devices#t=784) FDA Database Complexity and Integration
- [16:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-06-understanding-the-udi-system-for-medical-devices#t=984) Global Requirements and Software UDIs
- [21:14](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-06-understanding-the-udi-system-for-medical-devices#t=1274) Innovize Contract Manufacturing Services
- [24:35](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-06-understanding-the-udi-system-for-medical-devices#t=1475) Labeling Tiny Parts and Implantables
- [27:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-06-understanding-the-udi-system-for-medical-devices#t=1676) Standardization and Labeling Software

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)

## Most relevant to

established companies

## Mentioned

- Innovize (company)
- Consiliso (company)
- GS1 (other)
- HIBC (other)
- FDA (other)
- MDIC (company)
- Greenlight Guru (company)

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- [130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-03-130-qmsr-changes-to-traceability-reporting-independent-reviewer-risk-management) (Let's Combinate)
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- [Supply Chain Challenges in Medical Device Manufacturing](https://hardwarepodcasts.com/podcast/ontrack/2025-06-17-supply-chain-challenges-in-medical-device-manufacturing) (OnTrack)

## 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/2022-01-06-understanding-the-udi-system-for-medical-devices. 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.