# #390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-11-07
- Length: 37m
- Episode: 390
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-11-07-390-building-a-non-bs-qms-4-core-principles-for-medtech-success-with-ashkon-raso
- Listen: https://podcast.greenlight.guru/episode/390-designing-a-non-bs-qms

## Summary

Ashkon Rasooli, a quality and regulatory expert, joins host Etienne Nichols to outline four core principles for building an effective, non-burdensome Quality Management System (QMS) for medical device companies. Rasooli argues for 'Quality over Proceduralism,' 'Culture over Mandate,' 'Redundancy over Duplication,' and 'Conciseness over Verbosity' to ensure the QMS serves the business rather than just acting as a compliance checkbox. He advises new founders to engage quality and regulatory advisors early in the design phase to optimize architecture and avoid costly retrospective documentation. The discussion also covers the strategic decision of whether to treat quality as a minimum regulatory hurdle or a key business differentiator.

## Outline

1. Introduction: Ashkon Rasooli and the Non-BS QMS Concept
2. Principle 1: Quality Over Proceduralism and Managing Deviations
3. Principle 2: Building a Culture of Quality vs. Mandating Compliance
4. Principle 3: Redundancy vs. Duplication in Documentation
5. Principle 4: Conciseness Over Verbosity and Defining User Groups
6. Tactical Advice for New Founders: Early Engagement and Design for Quality

## Topics

- [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

## Mentioned

- Greenlight Guru (company)
- FDA (other)
- ISO 13485 (other)
- ISO 62304 (other)
- ISO 9001 (other)

## Related episodes from other shows

- [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)
- [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)
- [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)
- [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)

## 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/2024-11-07-390-building-a-non-bs-qms-4-core-principles-for-medtech-success-with-ashkon-raso. 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.