# #462: Implementing an eQMS: The Ultimate Move-In Guide for MedTech Leaders

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2026-06-29
- Length: 38m
- Episode: 462
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-06-29-462-implementing-an-eqms-the-ultimate-move-in-guide-for-medtech-leaders
- Listen: https://podcast.greenlight.guru/episode/implementing-an-eqms-the-ultimate-move-in-guide-for-medtech-leaders

## Summary

Michaela Kivett, a medical device consultant at Greenlight Guru, explains the strategic implementation of an electronic Quality Management System (eQMS) using a 'moving house' analogy to warn against simply migrating messy legacy data. She details the operational friction of paper-based or generic repository systems like SharePoint, highlighting issues with version control, physical signatures, and tracking personnel across large facilities. The conversation emphasizes leveraging AI to scan documents for ISO 13485 compliance gaps and automating workflow updates to mitigate the efficiency dip during transition. Kivett argues that successful adoption requires a culture of quality and a structured, room-by-room self-evaluation of procedures rather than just installing new software.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-06-29-462-implementing-an-eqms-the-ultimate-move-in-guide-for-medtech-leaders#t=0) Introduction: Michaela Kivett and Greenlight Guru
- [3:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-06-29-462-implementing-an-eqms-the-ultimate-move-in-guide-for-medtech-leaders#t=219) Operational Friction: Tracking People and Version Control Nightmares
- [8:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-06-29-462-implementing-an-eqms-the-ultimate-move-in-guide-for-medtech-leaders#t=485) Defining eQMS: SharePoint vs. Specialized Medical Device Software
- [12:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-06-29-462-implementing-an-eqms-the-ultimate-move-in-guide-for-medtech-leaders#t=754) The Rube Goldberg Illustration: Disconnected Spreadsheets and Manual Trackers
- [16:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-06-29-462-implementing-an-eqms-the-ultimate-move-in-guide-for-medtech-leaders#t=980) The Moving House Framework: Self-Evaluation Before Migration
- [21:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-06-29-462-implementing-an-eqms-the-ultimate-move-in-guide-for-medtech-leaders#t=1314) Mitigating the Efficiency Dip: AI and Professional Services
- [30:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-06-29-462-implementing-an-eqms-the-ultimate-move-in-guide-for-medtech-leaders#t=1830) Success Criteria: Culture of Quality and Training Matrices

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Scaling production](https://hardwarepodcasts.com/topic/scaling-production)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Greenlight Guru (company)
- SharePoint (tool)
- Google Drive (tool)
- ISO 13485 (other)
- ISO 14971 (other)
- ISO 62366 (other)

## Related episodes from other shows

- [205 - Why Less Than 20% of Companies Have Started Quality 4.0](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-11-205-why-less-than-20-of-companies-have-started-quality-4-0) (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)
- [Quality Management in a Changing Manufacturing Environment w/ Naveen Poonian](https://hardwarepodcasts.com/podcast/the-manufacturing-executive/2024-08-27-quality-management-in-a-changing-manufacturing-environment-w-naveen-poonian) (The Manufacturing Executive)
- [Digitizing Quality Management](https://hardwarepodcasts.com/podcast/the-manufacturing-executive/2022-08-09-digitizing-quality-management) (The Manufacturing Executive)
- [128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t) (Let's Combinate)

## Citing this page

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