# How to Build a QMS for a Medical Device

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-07-08
- Length: 44m
- Episode: 154
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-08-how-to-build-a-qms-for-a-medical-device
- Listen: https://podcast.greenlight.guru/episode/how-to-build-a-qms-for-a-medical-device

## Summary

Mike Drues, president of Vascular Sciences, and Jon Speer of Greenlight Guru discuss building a Quality Management System (QMS) for medical devices, emphasizing that it must be a philosophy of business rather than a compliance checklist. They identify key foundational sections for early-stage companies, including complaint handling, change management, risk management, and document control, while warning against copy-pasting templates. The conversation highlights the importance of accountability, traceability, consistency, and continuity, noting that FDA warning letters often stem from failures in these areas, such as undocumented complaint investigations or inconsistent document revision dates.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-08-how-to-build-a-qms-for-a-medical-device#t=0) Introduction: The Cost of Ignoring QMS
- [2:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-08-how-to-build-a-qms-for-a-medical-device#t=147) Defining QMS: Philosophy vs. Compliance
- [7:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-08-how-to-build-a-qms-for-a-medical-device#t=461) The Danger of Copy-Paste QMS Templates
- [11:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-08-how-to-build-a-qms-for-a-medical-device#t=676) Core Principles: Accountability, Traceability, Consistency, Continuity
- [16:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-08-how-to-build-a-qms-for-a-medical-device#t=994) Essential QMS Sections for Startups
- [25:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-08-how-to-build-a-qms-for-a-medical-device#t=1517) Beta Testing Change Management in R&D
- [28:09](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-08-how-to-build-a-qms-for-a-medical-device#t=1689) Risk Management and Post-Market Surveillance
- [31:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-08-how-to-build-a-qms-for-a-medical-device#t=1892) Document Control and Training as Living Processes

## 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)
- Vascular Sciences (company)
- FDA (other)
- Greenlight (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)
- [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)
- [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)
- [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

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-08-how-to-build-a-qms-for-a-medical-device. 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.