Hardware Podcasts

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

Global Medical Device Podcast · 21 Sept 2026 · 33m · Episode 474

What this episode covers

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.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Kapstone Medical, Boston Scientific, Stryker, Link BioCore
Also
FDA, ISO 13485, QMSR, MDSAP, UDI

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