# Quality Management for IVD Devices vs Medical Devices

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-04-05
- Length: 41m
- Episode: 193
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-05-quality-management-for-ivd-devices-vs-medical-devices
- Listen: https://podcast.greenlight.guru/episode/quality-management-for-ivd-devices-vs-medical-devices

## Summary

Joanne LeBrun of MDC Associates explains that while In Vitro Diagnostic (IVD) devices share quality management system (QMS) requirements with medical devices, they differ in performance proof, with IVDs often relying on leftover specimens rather than clinical studies. She highlights that the EU IVDR has significantly expanded regulation by changing device classification, while the pandemic has accelerated startup growth through contract manufacturing and molecular science advancements. LeBrun advises startups to avoid starting with a blank QMS, emphasizing the importance of robust internal audits, real-time documentation, and managing FDA inspections to prevent costly field failures and recalls.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-05-quality-management-for-ivd-devices-vs-medical-devices#t=0) Introduction: Joanne LeBrun and MDC Associates
- [2:18](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-05-quality-management-for-ivd-devices-vs-medical-devices#t=138) IVD vs Medical Device: Performance Proof and Regulatory Differences
- [6:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-05-quality-management-for-ivd-devices-vs-medical-devices#t=398) EU IVDR Classification Changes and Startup Growth Drivers
- [11:28](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-05-quality-management-for-ivd-devices-vs-medical-devices#t=688) Regulatory Speed vs. Startup Agility During the Pandemic
- [17:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-05-quality-management-for-ivd-devices-vs-medical-devices#t=1031) Avoiding Blank Slates: Using Templates and Contract Manufacturers
- [21:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-05-quality-management-for-ivd-devices-vs-medical-devices#t=1261) Managing FDA Inspections and Internal Quality Audits
- [32:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-05-quality-management-for-ivd-devices-vs-medical-devices#t=1944) Common Mistakes: Late Design Control and Poor Documentation
- [38:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-05-quality-management-for-ivd-devices-vs-medical-devices#t=2314) The Cost of Poor Design Control and Verification/Validation

## 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)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- MDC Associates (company)
- Greenlight Guru (company)
- Abbott Laboratories (company)
- EU MDR (other)
- IVDR (other)
- ISO 13485 (other)
- FDA (other)

## Related episodes from other shows

- [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)
- [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)
- [154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-18-154-ivds-ldts-companion-diagnostics-precision-medicine-clinical-validation-bioma) (Let's Combinate)
- [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)
- [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)

## 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/2021-04-05-quality-management-for-ivd-devices-vs-medical-devices. 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.