# #474: Behind the QMSR Audits: The Top 5 FDA Citations & Risk Management Pitfalls

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2026-09-21
- Length: 33m
- Episode: 474
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-09-21-474-behind-the-qmsr-audits-the-top-5-fda-citations-risk-management-pitfalls

## Summary

Nikhil Mangale, Vice President of Quality at Kapstone Medical, discusses the real-world impact of the FDA's Quality Management System Regulation (QMSR) based on seven months of inspection data. He identifies the top five FDA citations as risk management, supplier controls, complaint handling, Unique Device Identification (UDI), and corrective actions, noting that inspectors now focus on operational processes rather than terminology updates like renaming Design History Files (DHF) to Design and Development Files (DDF). Mangale advises companies to implement a three-layer mapping strategy, prioritize risk management as a living process, and maintain open DDFs throughout the product lifecycle to avoid citations. He also clarifies that ISO 13485 certification does not exempt companies from FDA inspections and highlights the continued value of MDSAP enrollment for sites in multiple jurisdictions.

## Outline

1. Introduction: Nikhil Mangale and Kapstone Medical
2. Top 5 FDA Citations Under QMSR
3. Risk Management: From Static File to Living Process
4. Supplier Controls and Audit Visibility
5. Complaint Handling, UDI, and Corrective Actions
6. Three-Layer Mapping Strategy for Compliance
7. Gap Assessments and Prioritized Quality Plans
8. Small Company QMS and Legacy Product Handling
9. ISO 13485 Certification, MDSAP, and ISO Revision

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Kapstone Medical (company)
- Boston Scientific (company)
- Stryker (company)
- Link BioCore (company)
- FDA (other)
- ISO 13485 (other)
- QMSR (other)
- MDSAP (other)
- UDI (other)

## Related episodes from other shows

- [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)
- [130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-03-130-qmsr-changes-to-traceability-reporting-independent-reviewer-risk-management) (Let's Combinate)
- [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)
- [127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-13-127-big-risk-management-changes-in-qmsr-risk-acceptability-risk-policy-explainin) (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/2026-09-21-474-behind-the-qmsr-audits-the-top-5-fda-citations-risk-management-pitfalls. 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.