# Meet a Guru: Brittani Smith

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-04-20
- Length: 29m
- Episode: 315
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-20-meet-a-guru-brittani-smith
- Listen: https://podcast.greenlight.guru/episode/meet-a-guru-brittani-smith

## Summary

Brittani Smith, a Medical Device Guru at Greenlight Guru, discusses her rapid career progression from regulatory coordinator to development engineering in just over two years. She emphasizes the importance of reading primary standards like ISO 13485 and 14971 to build confidence and avoid pitfalls in UDI and EU MDR implementation. Smith highlights the critical need for comprehensive documentation to prevent reliance on tribal knowledge and advises medical device professionals to assess risk and quality processes early in the design phase.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-20-meet-a-guru-brittani-smith#t=0) Introduction and Career Background
- [6:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-20-meet-a-guru-brittani-smith#t=361) Learning Regulatory and Quality on the Job
- [8:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-20-meet-a-guru-brittani-smith#t=491) Resources for Compliance: Standards and Webinars
- [11:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-20-meet-a-guru-brittani-smith#t=666) Building Social Capital and Navigating Company Dynamics
- [13:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-20-meet-a-guru-brittani-smith#t=814) Handling Bias and Youth in the Workplace
- [15:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-20-meet-a-guru-brittani-smith#t=902) The Role of a Medical Device Guru
- [18:48](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-20-meet-a-guru-brittani-smith#t=1128) Documentation Pitfalls and Change Control
- [23:40](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-20-meet-a-guru-brittani-smith#t=1420) Early Risk Assessment and Quality Culture

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- BSI (company)
- ISO 13485 (other)
- ISO 14971 (other)
- EU MDR (other)
- UDI (other)

## Related episodes from other shows

- [Etienne Nichols | How to Become a MedTech Engineer](https://hardwarepodcasts.com/podcast/being-an-engineer/2023-03-24-etienne-nichols-how-to-become-a-medtech-engineer) (Being an Engineer)
- [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)
- [S1E13 A Holistic View on Product Development | Devon Campbell](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-09-s1e13-a-holistic-view-on-product-development-devon-campbell) (Being an Engineer)
- [031 - "The Five Stages Of Regulatory Grief" with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott) (Let's Combinate)
- [025 - “The Frying Pan to the Fire” with Edwin Bills](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills) (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/2023-04-20-meet-a-guru-brittani-smith. 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.