# #431: Meet Alex Naber: Insider Insights on Quality Systems, Design Quality, and MedTech's Patient-First Ethos

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2025-11-03
- Length: 26m
- Episode: 431
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-11-03-431-meet-alex-naber-insider-insights-on-quality-systems-design-quality-and-medte
- Listen: https://podcast.greenlight.guru/episode/431-meet-alex-naber-insider-insights-on-quality-systems-design-quality-and-medtechs-patient-first-ethos

## Summary

Alex Naber, a medical device consultant at Greenlight Guru, discusses his career path from bioengineering to design quality and post-market management at Zimmer Biomet. He explains how Greenlight Guru's eQMS and EDC solutions eliminate the pain points of fragmented, spreadsheet-based design controls by building true, linked traceability directly into the system. Naber also highlights the value of pre-built QMS templates that accelerate implementation for small-to-midsize companies, avoiding the 'bloated' procedures typical of large corporations. Finally, he addresses the upcoming QMSR transition, reassuring listeners that compliance is manageable for those already adhering to ISO 13485.

## Chapters

- [0:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-11-03-431-meet-alex-naber-insider-insights-on-quality-systems-design-quality-and-medte#t=31) Introduction: Alex Naber and Greenlight Guru's Consultant Model
- [6:44](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-11-03-431-meet-alex-naber-insider-insights-on-quality-systems-design-quality-and-medte#t=404) The Problem with Spreadsheets: True Traceability in Greenlight Guru's eQMS
- [8:46](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-11-03-431-meet-alex-naber-insider-insights-on-quality-systems-design-quality-and-medte#t=526) Accelerating Compliance: Greenlight Guru's QMS Templates and Implementation
- [13:13](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-11-03-431-meet-alex-naber-insider-insights-on-quality-systems-design-quality-and-medte#t=793) Design Quality: Marrying R&D with QMS Compliance
- [16:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-11-03-431-meet-alex-naber-insider-insights-on-quality-systems-design-quality-and-medte#t=967) The MedTech Ethos: Patient-First Focus and Quality of Life
- [20:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-11-03-431-meet-alex-naber-insider-insights-on-quality-systems-design-quality-and-medte#t=1222) CAPA Management: Distinction Between Correction and Corrective Action
- [23:36](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-11-03-431-meet-alex-naber-insider-insights-on-quality-systems-design-quality-and-medte#t=1416) Navigating the QMSR Transition: ISO 13485 Compliance

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Greenlight Guru (company)
- Zimmer Biomet (company)
- High Ridge Medical (company)
- Tether (product)
- ISO 13485 (other)
- QMSR (other)
- FDA (other)

## Related episodes from other shows

- [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)
- [S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements) (Being an Engineer)
- [127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-13-127-big-risk-management-changes-in-qmsr-risk-acceptability-risk-policy-explainin) (Let's Combinate)
- [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)
- [100 - PQMCoach, Our First Recording, Quality (Big Q/little q), Why Predictive Quality Management, and Communicating Quality with Larry Mager](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-30-100-pqmcoach-our-first-recording-quality-big-q-little-q-why-predictive-quality-m) (Let's Combinate)

## 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/2025-11-03-431-meet-alex-naber-insider-insights-on-quality-systems-design-quality-and-medte. 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.