QMSR Compliance: What FDA Investigators Will Look for in 2026
The medical device industry is counting down to February 2, 2026, when the FDA’s Quality Management System Regulation (QMSR) formally replaces the old Quality System Regulation (QSR). Understanding how FDA investigators will inspect your QMS under QMSR is critical for compliance and operational excellence.
In this article, we break down what your organization should focus on to achieve QMSR compliance and prepare for inspections.
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QMSR: Moving Beyond Checklist Compliance
Under QMSR, FDA investigators will still review core subsystems of your QMS, such as CAPA, complaints, medical device reports, and risk management. However, the focus is now on system integration and real-world effectiveness, rather than just checking off procedures.
Key changes under QMSR inspections include:
- Data-driven, risk-based sampling: Inspectors may pull records across multiple QMS subsystems to test effectiveness.
- No exemptions: Internal audit reports, supplier audits, and management review records are now fully inspection-ready.
- Living QMS: Compliance requires a traceable, integrated system, not just documentation.
Complaint Handling Under QMSR
Complaint management remains grounded in 21 CFR Part 820.198, but with a stronger emphasis on integration with risk management and CAPA.
- Complaints must be treated as feedback, not isolated records.
- Documented processes should cover receipt, evaluation, investigation, and follow-up.
- Even if a complaint is not investigated, a justification must be documented.
- Complaints must influence risk assessments, CAPAs, and design or process changes.
Integrating complaints into your risk management and CAPA processes is critical for passing FDA inspections under QMSR.
Risk Management Under QMSR
Risk management is no longer a design-only checkbox; it’s now a lifecycle-wide, proactive process.
FDA investigators will expect:
- Risk-based planning and control for all critical processes.
- Validated monitoring and documentation proportionate to the risk level.
- Living risk files that reflect actual product performance and post-market data.
- Traceability between risk files, design controls, complaints, CAPAs, and other feedback.
Being able to demonstrate closed-loop integration between risk, CAPA, and complaints can significantly improve inspection performance.
Three Steps to Future-Proof Your QMS
- Run a Gap Analysis & Map Responsibilities:
Define clear escalation criteria, decision authorities, and train your team on the risk-based QMS mindset, not just procedures. - Implement Standardized Traceability:
Use unique identifiers and control numbers to link complaints, MDR decisions, and CAPAs. This turns your QMS into a coherent, traceable story. - Audit Like a Regulator:
Internal audits should simulate FDA inspections, focusing on performance, integration, and timeliness, not just the existence of procedures.
Is Your QMS Ready for QMSR?
To meet QMSR compliance and ensure smooth FDA inspections:
- Use a medtech-specific eQMS that supports paperless audits.
- Ensure top-notch regulatory expertise is available when needed.
- Maintain a living, traceable, integrated QMS that evolves with your product lifecycle.
At Operon Strategist, we help medical device companies achieve QMSR compliance and inspection readiness. Get your free QMSR readiness guide today and experience the power of a fully integrated, risk-based QMS.
Ensure Your QMS Is Inspection-Ready—Consult Our Experts Today!
Role of Operon Strategist in QMSR Compliance
At Operon Strategist, we guide medical device companies through every step of achieving QMSR compliance. From gap analysis, process mapping, and risk-based integration to preparing your team for FDA inspections, we ensure your QMS is inspection-ready, traceable, and fully aligned with regulatory expectations. Our experts also provide customized eQMS solutions, internal audit simulations, and complaint & CAPA management strategies, helping you streamline quality processes, mitigate risk, and accelerate regulatory readiness. Partnering with Operon Strategist means your QMS is not just compliant—it’s optimized for continuous improvement and long-term operational excellence.
