# FDA is Expanding its Case for Quality Program... Should Your Company Participate?

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2019-11-26
- Length: 36m
- Episode: 125
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-fda-is-expanding-its-case-for-quality-program-should-your-company-participate
- Listen: https://podcast.greenlight.guru/episode/fda-is-expanding-its-case-for-quality-program-should-your-company-participate

## Summary

Mike Drues of Vascular Sciences and John Spear of Greenlight Guru discuss the FDA's expansion of the Case for Quality initiative, a pilot program involving the CMMI Institute and MDIC that shifts focus from mere compliance to true product quality. They analyze the benefits for participating companies, such as exemption from routine inspections and expedited PMA supplement reviews, while debating whether the program's inclusion of non-compliant companies constitutes helpful guidance or inappropriate micromanagement. The conversation highlights the tension between regulatory hurdles and the need for continuous improvement in medical device manufacturing.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-fda-is-expanding-its-case-for-quality-program-should-your-company-participate#t=0) Introduction: Mike Drues and the Case for Quality Initiative
- [1:57](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-fda-is-expanding-its-case-for-quality-program-should-your-company-participate#t=117) Program Premise: CMMI Institute, MDIC, and FDA Partnership
- [8:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-fda-is-expanding-its-case-for-quality-program-should-your-company-participate#t=497) Benefits: Inspection Exemption and PMA Supplement Incentives
- [14:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-fda-is-expanding-its-case-for-quality-program-should-your-company-participate#t=860) PMA Change Management: ETO Sterilization and Regulatory Hurdles
- [22:59](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-fda-is-expanding-its-case-for-quality-program-should-your-company-participate#t=1379) Appraisal Methodology: CMMI Models and Non-Compliant Companies
- [27:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-fda-is-expanding-its-case-for-quality-program-should-your-company-participate#t=1665) Debate: FDA's Role in Helping Non-Compliant Companies
- [34:15](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-fda-is-expanding-its-case-for-quality-program-should-your-company-participate#t=2055) Conclusion: True Quality vs. Compliance Mindset

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Greenlight Guru (company)
- Vascular Sciences (company)
- FDA (other)
- MDIC (other)
- CMMI Institute (other)
- CMMI (other)

## Related episodes from other shows

- [155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-25-155-fda-compliance-programs-program-7536-000-cder-vs-cdrh-led-inspections-mock-p) (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)
- [256 - The New FDA Inspection Playbook: Where to Start with QMSR](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-28-256-the-new-fda-inspection-playbook-where-to-start-with-qmsr) (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)

## 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/2019-11-26-fda-is-expanding-its-case-for-quality-program-should-your-company-participate. 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.