# #370: Meet a Guru: Jamie Bihary

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-05-30
- Length: 32m
- Episode: 370
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-30-370-meet-a-guru-jamie-bihary
- Listen: https://podcast.greenlight.guru/episode/370-onboarding-with-greenlight-guru

## Summary

Jamie Bihary, a Medical Device Guru at Greenlight Guru, explains her transition from biomedical engineering to helping companies migrate from legacy Quality Management Systems (QMS) to electronic QMS (EQMS). She details the challenges of document migration, emphasizing the importance of clean room environmental monitoring to prevent endotoxin contamination and the value of internal audits in maintaining compliance. Bihary highlights Greenlight Guru’s partner network and support systems, advising startups to leverage consultants and realistic planning to navigate the complexities of QMS implementation.

## Outline

1. Introduction: Jamie Bihary and her role at Greenlight Guru
2. Day in the life: Onboarding and implementation for new MedTech companies
3. Common challenges: Where to start and establishing implementation plans
4. Bihary’s origin story: From tissue engineering to quality engineering
5. EQMS implementation: Validated software and document migration with Anne Slevin
6. Clean room environmental monitoring: Aseptic techniques and contamination control
7. Legacy system transition: Managing 10 years of records and audit trails
8. Internal audits and feedback culture: Dealing with GDP errors and management
9. Greenlight Guru’s partner network and resources for small teams
10. Key advice: Resource allocation and leveraging the Guru Edge

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Greenlight Guru (company)
- FDA (other)
- BSI (other)
- ISO 13485 (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)
- [215 - Why Aren’t Technical People Leading Drug-Device Audits?](https://hardwarepodcasts.com/podcast/lets-combinate/2025-11-26-215-why-arent-technical-people-leading-drug-device-audits) (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)
- [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)
- [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)

## Citing this page

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