# Meet a Guru: Karen Schuyler

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-03-08
- Length: 25m
- Episode: 185
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-08-meet-a-guru-karen-schuyler
- Listen: https://podcast.greenlight.guru/episode/meet-a-guru-karen-schuyler

## Summary

Karen Schuyler, a Medical Device Guru at Greenlight Guru, discusses her 15-year career spanning product engineering at Gore, startup scaling, and quality strategy at large medical device companies. She highlights the industry's shift toward collaborative regulatory approaches and the challenges of adapting to frequent standard updates like ISO 13485 and EU MDR. Schuyler explains how Greenlight Guru’s software solves the inefficiency of manual traceability by automating linkages between design controls, risk management, and documentation, preventing the 'painting yourself into a corner' scenarios common in legacy systems.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-08-meet-a-guru-karen-schuyler#t=0) Introduction and Karen Schuyler's Background
- [6:40](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-08-meet-a-guru-karen-schuyler#t=400) Regulatory Changes and Collaborative Audits
- [10:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-08-meet-a-guru-karen-schuyler#t=629) Managing ISO 13485 and EU MDR Transitions
- [14:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-08-meet-a-guru-karen-schuyler#t=870) Greenlight Guru Software Value Proposition
- [20:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-08-meet-a-guru-karen-schuyler#t=1241) Keys to Success for Medical Device Professionals

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [EDA & CAD tools](https://hardwarepodcasts.com/topic/eda-and-cad-tools)

## Most relevant to

companies scaling up

## Mentioned

- Greenlight Guru (company)
- Gore (company)
- ISO 13485 (other)
- EU MDR (other)
- Product (company)

## 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)
- [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)
- [Weronika Michaluk on Medical Devices development](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-09-04-weronika-michaluk-on-medical-devices-development) (The Pragmatic Embedded Podcast)
- [130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-03-130-qmsr-changes-to-traceability-reporting-independent-reviewer-risk-management) (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/2021-03-08-meet-a-guru-karen-schuyler. 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.