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Preparing for the FDA's Quality Management System Regulation (QMSR)

A practical guide for medical device firms

The medical device industry is on the cusp of a significant regulatory shift as the FDA harmonizes the QSR with ISO 13486:2016. Is your organization ready?

This comprehensive white paper is your essential guide to navigating the transition from the FDA's QSR to the new Quality Management System Regulation (QMSR).

Inside, you'll discover:

• A Deep Dive into QMSR: Understand the key changes, their implications, and how they align with ISO 13485:2016.
• Transition Timeline and Strategy: Get a clear roadmap for compliance, including critical deadlines and actionable steps.
• Risk Management Focus: Learn how to integrate robust risk management practices throughout your quality system.
• Inspection Readiness: Prepare for the new inspection landscape under QMSR.
• Gap Analysis Guidance: Identify and address discrepancies between your current QMS and QMSR requirements.
• Checklist: Get our exclusive QMSR Transition Checklist to track your progress and ensure no critical steps are missed.

Whether you're ISO 13485 certified or primarily QSR compliant, this white paper provides invaluable insights to ensure a smooth transition to QMSR.

Don't let the February 2026 deadline catch you off guard. Download our free white paper now and take the first step towards QMSR compliance. ⤵️