# #329 The Right Way to Start a QMS: When, How, & What

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-07-27
- Length: 54m
- Episode: 329
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-27-329-the-right-way-to-start-a-qms-when-how-what
- Listen: https://podcast.greenlight.guru/episode/the-right-way-to-start-a-qms-when-how-what

## Summary

Rob MacCuspie, Manager of Regulatory and Quality Affairs at Proxima Clinical Research, explains how to build a Quality Management System (QMS) by balancing investor cost concerns with FDA regulatory requirements. He argues that a QMS is not just a document management system but a culture driven by management responsibility and people, using a 'highway vs. mountain road' analogy to describe risk-based rigor for different device classes. MacCuspie details the phased implementation of QMS components, the specific challenges of Software as a Medical Device (SaMD) regarding labeling and testing, and the operational efficiency gains of moving from paper to compliant electronic systems like Greenlight Guru.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-27-329-the-right-way-to-start-a-qms-when-how-what#t=0) Introduction: Rob MacCuspie and Proxima Clinical Research
- [2:57](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-27-329-the-right-way-to-start-a-qms-when-how-what#t=177) Defining QMS: The Highway vs. Mountain Road Analogy
- [5:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-27-329-the-right-way-to-start-a-qms-when-how-what#t=342) When to Start: Balancing Investor Costs and FDA Requirements
- [12:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-27-329-the-right-way-to-start-a-qms-when-how-what#t=776) Risk-Based Rigor: Class 3 Implants vs. Class 1 Bandages
- [16:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-27-329-the-right-way-to-start-a-qms-when-how-what#t=999) The Human Element: People, Management, and Culture
- [22:57](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-27-329-the-right-way-to-start-a-qms-when-how-what#t=1377) Software as a Medical Device (SaMD) and Regulatory Tension
- [30:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-27-329-the-right-way-to-start-a-qms-when-how-what#t=1855) Labeling Nuances for Software and Marketing Claims
- [34:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-27-329-the-right-way-to-start-a-qms-when-how-what#t=2095) Building a QMS Roadmap and Document Control Strategies
- [46:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-27-329-the-right-way-to-start-a-qms-when-how-what#t=2768) Transitioning from Paper to Electronic QMS Tools

## 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)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Proxima Clinical Research (company)
- Greenlight Guru (company)
- FDA (other)
- ISO 13485 (other)
- 21 CFR Part 820 (other)
- QMSR (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)
- [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)
- [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)
- [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)

## Citing this page

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