# 256 - The New FDA Inspection Playbook: Where to Start with QMSR

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-09-28
- Length: 9m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-28-256-the-new-fda-inspection-playbook-where-to-start-with-qmsr
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/256---The-New-FDA-Inspection-Playbook-Where-to-Start-with-QMSR-e3pfkki

## Summary

Subhi Saadeh, founder of Let’s Combinate, introduces a four-part series on FDA inspection readiness under the new Quality Management System Regulation (QMSR), explaining how the retired QSIT framework has been replaced by Compliance Program 7382.850. He highlights advice from former FDA investigator Eric Pittman, who advises industry to focus exclusively on Section III of compliance programs as the primary roadmap for inspections. The episode details the shift from QSIT’s four major subsystems to six QMS areas, emphasizing a risk-based approach where investigators evaluate product risks and control effectiveness.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-28-256-the-new-fda-inspection-playbook-where-to-start-with-qmsr#t=0) Introduction: QMSR Effectiveness and QSIT Retirement
- [3:20](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-28-256-the-new-fda-inspection-playbook-where-to-start-with-qmsr#t=200) Eric Pittman: Prioritizing Section III of Compliance Programs
- [4:14](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-28-256-the-new-fda-inspection-playbook-where-to-start-with-qmsr#t=254) QSIT vs. QMSR: Comparing Inspection Approaches

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

large enterprises

## Mentioned

- FDA (company)
- QMSR (other)
- QSIT (other)
- ISO 13485 (other)
- Compliance Program 7382.850 (other)
- Let’s Combinate (company)

## Related episodes from other shows

- [#474: Behind the QMSR Audits: The Top 5 FDA Citations & Risk Management Pitfalls](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-09-21-474-behind-the-qmsr-audits-the-top-5-fda-citations-risk-management-pitfalls) (Global Medical Device Podcast)
- [#438: QMSR Mythbusters Episode](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-22-438-qmsr-mythbusters-episode) (Global Medical Device Podcast)
- [QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-16-qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices) (Global Medical Device Podcast)
- [#329 The Right Way to Start a QMS: When, How, & What](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-27-329-the-right-way-to-start-a-qms-when-how-what) (Global Medical Device Podcast)
- [#360: Is It Possible to "Buy" a QMS?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-11-360-is-it-possible-to-buy-a-qms) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-28-256-the-new-fda-inspection-playbook-where-to-start-with-qmsr. 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 Let's Combinate.