# 003 - “Standard Understanding” with Mark Swanson

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2021-10-20
- Length: 54m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-20-003-standard-understanding-with-mark-swanson
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/003---Standard-Understanding-with-Mark-Swanson-e18ue8e

## Summary

Mark Swanson, President of QRx Partners, discusses his extensive background in medical device quality, including his work on the ISO 13485:2016 revision and ISO 9001:2015 standards. He explains the consensus-driven process of writing international standards, highlighting the semantic challenges of terms like 'and/or' and the specific risk definitions in medical device regulations versus generic business standards. Swanson also details the practical implications of ISO 13485 certification for small to mid-sized companies, weighing the $30,000 annual cost against regulatory requirements and market access.

## Chapters

- [0:01](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-20-003-standard-understanding-with-mark-swanson#t=1) Introduction: Mark Swanson and QRx Partners
- [2:03](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-20-003-standard-understanding-with-mark-swanson#t=123) Swanson's Career: From Naval Officer to Quality at Medtronic
- [5:05](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-20-003-standard-understanding-with-mark-swanson#t=305) The ISO 13485:2016 Revision Process and Consensus Building
- [12:43](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-20-003-standard-understanding-with-mark-swanson#t=763) ISO Governance: National Bodies, Voting Thresholds, and Systematic Reviews
- [19:49](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-20-003-standard-understanding-with-mark-swanson#t=1189) Differences Between ISO 13485 and ISO 9001: Risk and Sterility
- [33:35](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-20-003-standard-understanding-with-mark-swanson#t=2015) The Cost and Value of ISO 13485 Certification for Small Companies
- [38:45](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-20-003-standard-understanding-with-mark-swanson#t=2325) Consulting Strategy: Fractional Quality and Regulatory Support for Startups
- [44:46](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-20-003-standard-understanding-with-mark-swanson#t=2686) Education and Leadership: St. Cloud State University and Mentorship

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies

## Mentioned

- QRx Partners (company)
- Medtronic (company)
- ISO 13485 (other)
- ISO 9001 (other)
- AAMI (company)
- ASQ (company)
- Traction (other)

## Related episodes from other shows

- [#404: MedTech 101: What You Need to Know About the Medical Device Industry](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-05-01-404-medtech-101-what-you-need-to-know-about-the-medical-device-industry) (Global Medical Device Podcast)
- [#383: What Standards Apply to My Device?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-09-19-383-what-standards-apply-to-my-device) (Global Medical Device Podcast)
- [Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-10-inside-look-into-iso-14971-2019-iso-tr-24971-2020-from-the-authors-point-of-view) (Global Medical Device Podcast)
- [QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-16-qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices) (Global Medical Device Podcast)
- [Meet a Guru: Maryann Mitchell](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-02-meet-a-guru-maryann-mitchell) (Global Medical Device Podcast)

## Citing this page

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