# #412: How to Build a QMS That Actually Works: From Startup to Scale in MedTech

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2025-06-23
- Length: 16m
- Episode: 412
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-06-23-412-how-to-build-a-qms-that-actually-works-from-startup-to-scale-in-medtech
- Listen: https://podcast.greenlight.guru/episode/415-the-non-bs-burdensome-qms-approach

## Summary

Ashkon Rasooli, speaking at the LSI conference, outlines a phased approach to building a Quality Management System (QMS) for medical device startups, arguing that compliance should be integrated early to avoid being burdensome. He introduces a 'Phase 0–6' model, advising founders to build a quality culture during the feasibility phase rather than implementing formal controls too early. Rasooli emphasizes anticipating 'enforcement points' from regulators like the FDA or investors, rather than reacting to them at product launch, to ensure smoother design transfer and post-market surveillance.

## Outline

1. Introduction and QMS Philosophy
2. The Phase 0–6 Product Development Model
3. Building Quality Culture in Feasibility
4. Defining Quality Policy and Strategy
5. Anticipating Enforcement Points
6. Proactive Planning for Design and Testing
7. Final Advice for Startups

## Topics

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

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Greenlight Guru (company)
- FDA (other)
- ISO 13485 (other)
- ISO 9001 (other)
- ISO 14155 (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)
- [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)
- [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)
- [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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