# Meet a Guru: Erica Loring

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-10-28
- Length: 38m
- Episode: 165
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-10-28-meet-a-guru-erica-loring
- Listen: https://podcast.greenlight.guru/episode/meet-a-guru-erica-loring

## Summary

Erica Loring, a medical device guru at Greenlight Guru, discusses her background in pharmaceuticals and IVDs, emphasizing the critical distinction between Quality Assurance and Regulatory Affairs. She explains how the 'throw it over the wall' mentality creates documentation gaps and costly remediation, advocating for cross-functional collaboration from concept to market. Loring highlights the importance of investing in people, allowing adequate time for development, and rigorously auditing suppliers to ensure successful product launches.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-10-28-meet-a-guru-erica-loring#t=0) Introduction: Erica Loring and Greenlight Guru's Guru Edge
- [2:14](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-10-28-meet-a-guru-erica-loring#t=134) Erica Loring's Career Journey: From Pharma to IVDs
- [9:59](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-10-28-meet-a-guru-erica-loring#t=599) Distinguishing Quality Assurance from Regulatory Affairs
- [13:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-10-28-meet-a-guru-erica-loring#t=786) The 'Throw It Over the Wall' Problem and Design History Files
- [19:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-10-28-meet-a-guru-erica-loring#t=1157) Quality as a Bottleneck vs. Enabler in Product Development
- [23:59](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-10-28-meet-a-guru-erica-loring#t=1439) Case Study: Helping Breathe 99 with Mask Regulatory Pathways
- [29:43](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-10-28-meet-a-guru-erica-loring#t=1783) Key Success Factors: People, Time, and Supplier Audits

## Topics

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

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- Lonza Biologics (company)
- Cook Medical (company)
- Master Control (company)
- Breathe 99 (company)
- Masks On (company)
- FDA (other)
- ISO 13485 (other)
- 510(k) (other)
- EUA (other)

## Related episodes from other shows

- [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)
- [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)
- [066 -Scientist to CSO, Learning QA/RA & Marketing, and Saying Yes to Oppurtunities with Fran DeGrazio](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-04-066-scientist-to-cso-learning-qa-ra-marketing-and-saying-yes-to-oppurtunities-wi) (Let's Combinate)
- [210 - The 8 Roles You MUST Understand in Pharma & MedTech](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-22-210-the-8-roles-you-must-understand-in-pharma-medtech) (Let's Combinate)
- [244 - 5 Critical Quality Differences Between Drugs and Devices](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-01-244-5-critical-quality-differences-between-drugs-and-devices) (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/2020-10-28-meet-a-guru-erica-loring. 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.