# Meet a Guru: Sara Adams

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-03-17
- Length: 20m
- Episode: 188
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-17-meet-a-guru-sara-adams
- Listen: https://podcast.greenlight.guru/episode/meet-a-guru-sara-adams

## Summary

Sara Adams, a medical device guru at Greenlight Guru, discusses her background as a quality engineer and her experience implementing an electronic Quality Management System (QMS) at a previous employer. She explains the challenges of transitioning from a paper-based system, emphasizing the importance of laying a strong foundation through documents and training to manage employee resistance to change. Adams also highlights the industry shift toward virtual audits during the pandemic and stresses the importance of understanding ISO 13485 and FDA requirements for medical device companies.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-17-meet-a-guru-sara-adams#t=0) Introduction: Sara Adams and Greenlight Guru's Guru Edge
- [2:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-17-meet-a-guru-sara-adams#t=120) Sara Adams' Background: Biomedical Engineering and Quality Roles
- [5:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-17-meet-a-guru-sara-adams#t=320) Motivation for Medical Devices: Helping Patients and Engineering
- [8:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-17-meet-a-guru-sara-adams#t=533) Implementing Electronic QMS: Challenges of Change and Resistance
- [13:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-17-meet-a-guru-sara-adams#t=813) Light Bulb Moments: Efficiency Gains from Digital Workflows
- [14:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-17-meet-a-guru-sara-adams#t=894) Industry Challenges: The Shift to Virtual Audits in 2020-2021
- [16:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-17-meet-a-guru-sara-adams#t=1013) Success Factors: ISO 13485, FDA Requirements, and Guru Support

## 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)
- [Direct-to-consumer & e-commerce](https://hardwarepodcasts.com/topic/direct-to-consumer)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- Sara Adams (other)
- John Spear (other)
- ISO 13485 (other)
- FDA (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)
- [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)
- [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)
- [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

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-17-meet-a-guru-sara-adams. 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.