WEBINAR

The Hidden Risks in the FDA Quality Management System Regulation (QMSR)

 

Hear from Michelle Keane, QA/RA Director at Comply Guru, and Sara Adams, Senior Consultant at Dot Compliance, for an actionable session designed specifically for medical device quality and regulatory professionals. They break down what “risk” really means under QMSR, highlight the hidden areas where the FDA expects risk-based decision-making, and discuss practical strategies for preparing your teams and processes.

 

Key Points:

  • Clarifying Risk Under QMSR: Get a high-level introduction to what “risk” really means in the FDA’s new QMSR and how it differs from traditional product-only risk thinking.
  • Spotting Hidden Risk Areas: Learn how Management Review, Internal Audits, and Supplier Controls all carry elevated risk under QMSR—and why the FDA will expect stronger, risk-based justification in each.
  • Preparing Your QMS for QMSR: Understand how to apply risk-based thinking across your quality system so your organization is aligned, inspection-ready, and confident heading into 2026.

Whether you’re leading a quality system overhaul or optimizing for the new regulation, this webinar helps you identify blind spots and strengthen your organization’s readiness.

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