FDA’s QMSR Readiness Checklist for Medical Device Manufacturers

Prepare for the February 2026 Deadline with Confidence

The FDA’s Quality Management System Regulation (QMSR) is replacing the long-standing Quality System Regulation (QSR), aligning U.S. medical device compliance with ISO 13485:2016. This shift, effective February 2, 2026, marks a major milestone in global harmonization and regulatory modernization.

To help medical device manufacturers navigate this transition, ComplianceQuest has created a comprehensive QMSR Readiness Checklist—your go-to resource for ensuring compliance, minimizing risk, and maintaining product quality.

What’s Inside the QMSR Prep Checklist?

This free, downloadable checklist helps you:

• Assess your current QMS against QMSR and ISO 13485 standards
• Identify compliance gaps and prioritize high-risk areas
• Plan and execute transition actions with clear ownership and timelines
• Train your teams with role-based QMSR education
• Update documentation and Medical Device Files (MDFs)
• Strengthen risk management aligned with ISO 14971:2019
• Conduct internal audits and track CAPA effectiveness
• Drive continuous improvement through management reviews and compliance metrics

Why You Need to Act Now

Manual systems and outdated processes won’t meet the FDA’s new inspection standards. The QMSR demands real-time visibility, traceability, and audit-readiness across your quality operations.

With ComplianceQuest’s AI-powered EQMS, you can:

• Automate documentation, training, and audit trails
• Centralize risk, CAPA, and MDF management
• Prove compliance with dashboards and inspection-ready reports

ComplianceQuest’s platform supports FDA QMSR, ISO 13485, EU MDR, and other global standards—making it ideal for multi-site, multi-country manufacturers.

Download the Checklist & Future-Proof Your Compliance

Don’t wait until the last minute. Download the checklist and start your QMSR transition today.