FDA’s QMSR is Coming: Practical Readiness for Quality Teams

Overview:

With the FDA’s Quality Management System Regulation (QMSR) taking effect in February 2026, medical device manufacturers are entering one of the most significant quality-system shifts in decades. The replacement of the long-standing Quality System Regulation (QSR) with a framework that integrates ISO 13485 into 21 CFR Part 820 is not a simple regulatory update—it represents a fundamental change in how quality systems are expected to function.

This course provides a practical explanation of what the QMSR is, why it matters, and how it reshapes FDA expectations. While the new regulation aligns U.S. requirements more closely with ISO 13485, it also retains key FDA-specific provisions and introduces a stronger emphasis on risk-based thinking across all Quality System processes. Organizations that view compliance as a documentation exercise will find that approach insufficient under QMSR. The focus has shifted decisively from “what documents exist” to how well processes control quality and risk.

A central pillar of QMSR is the application of risk evaluation to Quality System processes, not just to product design. However, the regulation itself does not prescribe how manufacturers should perform this analysis. This session bridges that gap by explaining the Hazard Analysis approach aligned with ISO 14971 and demonstrating how it can be applied meaningfully to core QS processes such as supplier control, CAPA, change control, and training.

The webinar also addresses two areas where FDA expectations have become notably stronger: top management involvement and supplier oversight. Senior leadership is now expected to play an active, accountable role in the Quality System, and supplier controls must be demonstrably risk-based and robust. Attendees will gain clarity on what FDA investigators are likely to look for during inspections and where organizations commonly fall short during transitions to new regulatory frameworks.

By the end of this session, participants will have a clearer understanding of how QMSR changes the definition of “quality,” what practical adjustments may be needed within their existing systems, and why conformance to ISO 13485 alone is no longer enough without integrated, risk-based quality processes.

Areas covered in the session:

• ISO 13485
• QMSR requirements
• Retained sections of 21 CFR 820
• Hazard analysis procedure
• How to apply risk analysis to QS processes
• FDA inspections

Why should you attend?

If you’re responsible for quality, regulatory, or compliance in a medical device organization, the FDA’s QMSR effective February 2026 is not a change you can “absorb later.” It reshapes how FDA expectations align with ISO 13485 while retaining important FDA-specific elements, and it raises the bar on how your quality system is expected to function—not just what documents you maintain.

This session will help you clearly understand what is changing from QSR to QMSR, what is being retained, and where organizations are most likely to misjudge the transition. You’ll also get a practical explanation of how risk evaluation is expected to be applied to quality system processes—something the rule emphasizes, but doesn’t spell out step-by-step.

If your current approach leans heavily on documentation rather than risk-based, integrated processes, this webinar will help you refocus on what “good” will look like in a QMSR world.

Handouts:

Attendees will receive exclusive handouts, including the speaker’s presentation materials plus Amorit Education resources such as a QSR → QMSR Transition Comparison Matrix and an ISO 14971-aligned Hazard Analysis-to-QS Processes handout to help teams translate the session into practical next steps.

Who will benefit?

This webinar is designed for professionals involved in quality, regulatory, compliance, and operational oversight within medical device organizations. Those include:

• Quality Assurance Manager
• Quality Systems Manager
• Quality Engineer
• Quality Compliance Specialist
• Regulatory Affairs Manager
• Regulatory Affairs Specialist
• Compliance Manager
• Internal Auditor
• Lead Auditor
• Supplier Quality Engineer
• Supplier Quality Manager
• CAPA Coordinator
• Change Control Coordinator
• Document Control Specialist
• Training Coordinator
• Manufacturing/Operations Manager
• Process Engineer