# Meet a Guru: Maryann Mitchell

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-09-02
- Length: 15m
- Episode: 226
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-02-meet-a-guru-maryann-mitchell
- Listen: https://podcast.greenlight.guru/episode/meet-a-guru-maryann-mitchell

## Summary

Maryann Mitchell, a Solutions Engineer at Greenlight Guru, discusses her background in quality systems and her role helping medical device companies evaluate the Greenlight Guru Medical Device Success Platform (MDSP). She highlights the platform's ability to streamline design control and risk matrices, which helps companies achieve audit readiness and faster ISO 13485 compliance. Mitchell also addresses current industry challenges, specifically the complexities of EU MDR submissions and the potential transition of FDA inspections toward ISO 13485 standards.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-02-meet-a-guru-maryann-mitchell#t=0) Introduction: Maryann Mitchell and Greenlight Guru
- [1:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-02-meet-a-guru-maryann-mitchell#t=98) Maryann's Role as a Solutions Engineer
- [2:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-02-meet-a-guru-maryann-mitchell#t=147) Career History: From Receptionist to Global Compliance Manager
- [3:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-02-meet-a-guru-maryann-mitchell#t=210) The Excitement of Audits and FDA Inspections
- [5:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-02-meet-a-guru-maryann-mitchell#t=305) Joining Greenlight Guru and Software Evaluation
- [7:09](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-02-meet-a-guru-maryann-mitchell#t=429) Customer Stories: Design Control and Risk Matrices
- [9:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-02-meet-a-guru-maryann-mitchell#t=581) EU MDR Challenges and Interconnectivity
- [10:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-02-meet-a-guru-maryann-mitchell#t=638) FDA Transition to ISO 13485 and Audit Readiness
- [12:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-02-meet-a-guru-maryann-mitchell#t=745) Tips for Success and Quality Culture

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Direct-to-consumer & e-commerce](https://hardwarepodcasts.com/topic/direct-to-consumer)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- Greenlight Guru Medical Device Success Platform (product)
- ISO 13485 (other)
- FDA (other)
- EU MDR (other)
- EU IVDR (other)
- ETQ (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)
- [170 - The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)](https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-08-170-the-1-secret-to-understanding-iso-13485-youll-wish-you-knew-sooner) (Let's Combinate)
- [003 - “Standard Understanding” with Mark Swanson](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-20-003-standard-understanding-with-mark-swanson) (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)
- [198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-23-198-qmsr-explained-iso-13485-compared-and-5-key-things-you-mightve-missed) (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/2021-09-02-meet-a-guru-maryann-mitchell. 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.