# #417: Evaluating EQMS: A Crucial Step for Medtech Success

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2025-07-28
- Length: 43m
- Episode: 417
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-07-28-417-evaluating-eqms-a-crucial-step-for-medtech-success
- Listen: https://podcast.greenlight.guru/episode/evaluating-eqms-a-crucial-step-for-medtech-success

## Summary

Andy Rogantino, an account executive at Greenlight Guru, joins host Etienne Nichols to discuss the strategic evaluation and implementation of Electronic Quality Management Systems (EQMS) for medical device companies. They argue that teams should integrate an EQMS early in the product lifecycle rather than waiting for regulatory crises, emphasizing the need to involve cross-functional stakeholders including product development, regulatory, IT, and leadership. The conversation details key evaluation criteria, such as ensuring the software is purpose-built for MedTech compliance with standards like ISO 13485 and 21 CFR Part 820, while avoiding overly customizable generic platforms that hinder adoption.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-07-28-417-evaluating-eqms-a-crucial-step-for-medtech-success#t=0) Introduction: Andy Rogantino and Greenlight Guru
- [3:13](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-07-28-417-evaluating-eqms-a-crucial-step-for-medtech-success#t=193) Timing EQMS Evaluation: Preventing Regulatory Fires
- [4:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-07-28-417-evaluating-eqms-a-crucial-step-for-medtech-success#t=267) Prioritizing EQMS: The Three Pillars of MedTech
- [11:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-07-28-417-evaluating-eqms-a-crucial-step-for-medtech-success#t=713) Stakeholder Involvement: Breaking Down Quality Island
- [17:13](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-07-28-417-evaluating-eqms-a-crucial-step-for-medtech-success#t=1033) Evaluation Criteria: Purpose-Built vs. Generic Software
- [22:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-07-28-417-evaluating-eqms-a-crucial-step-for-medtech-success#t=1375) User Experience and Interface Design in QMS
- [26:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-07-28-417-evaluating-eqms-a-crucial-step-for-medtech-success#t=1613) Navigating Sales Demos and Success Criteria
- [31:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-07-28-417-evaluating-eqms-a-crucial-step-for-medtech-success#t=1905) Pitfalls to Avoid: Complexity and Speed
- [35:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-07-28-417-evaluating-eqms-a-crucial-step-for-medtech-success#t=2150) The Compounding Risk of Inaction
- [40:23](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-07-28-417-evaluating-eqms-a-crucial-step-for-medtech-success#t=2423) Integrating Clinical Data and EDC

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Greenlight Guru (company)
- Abies (company)
- Signal Therapeutics (company)
- Decro (company)
- Linskin Golf (product)
- 2nd Nature (company)
- Moderna (company)
- Hulu (company)
- Activision (company)
- Call of Duty (product)

## 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)
- [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)
- [215 - Why Aren’t Technical People Leading Drug-Device Audits?](https://hardwarepodcasts.com/podcast/lets-combinate/2025-11-26-215-why-arent-technical-people-leading-drug-device-audits) (Let's Combinate)
- [256 - The New FDA Inspection Playbook: Where to Start with QMSR](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-28-256-the-new-fda-inspection-playbook-where-to-start-with-qmsr) (Let's Combinate)

## Citing this page

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