FDA QMSR Final Rule 2024: ISO 13485 Transition & Compliance Guide for Medical Device Manufacturers

On February 2, 2024, the FDA published the final rule for the Quality Management System Regulation (QMSR), replacing the long-standing Quality System Regulation (QSR) under 21 CFR Part 820. This update incorporates ISO 13485:2016 as the new foundation for medical device quality management systems, introducing significant changes for manufacturers, especially those not previously aligned with ISO 13485. For a deeper dive into this, click here.

In this video, Mike Wolf, CMDA, CQA, RAC (Director of Client Services at Theoris), explains the core updates, which requirements remain from the QSR, and practical steps to prepare for the February 2, 2026 compliance date.

What is the FDA QMSR?

The FDA’s QMSR is designed to harmonize U.S. quality management requirements with internationally recognized standards. By incorporating ISO 13485:2016, the FDA aims to reduce compliance burdens for manufacturers operating globally while maintaining device safety and effectiveness.

Key Changes from QSR to QMSR

While many requirements will feel familiar, QMSR introduces or emphasizes several elements:

• Risk-based QMS processes: Greater focus on risk management in all quality processes.
• Competency vs. training: Demonstrating employee competency, not just training completion.
• Management review: More prescriptive requirements for reviewing QMS performance.
• Supplier controls: Enhanced expectations for evaluating and managing suppliers.
• Process & software validation: Clearer emphasis on validation activities for critical processes.

FDA-Specific Requirements that Remain

Even ISO 13485-certified companies must address QMSR’s FDA-specific elements, including:

• Traceability for life-sustaining devices
• Complaint, service, and UDI records
• Labeling and packaging compliance requirements

How Theoris Can Help

Our Quality and Compliance Consulting team offers:

• Gap Analysis: Identify differences between your current QMS and QMSR requirements.
• Staff Training: Build organizational awareness and competency for new requirements.
• Documentation Updates: Revise quality manuals, SOPs, work instructions, and templates.
• Risk Management Support: Implement and document a robust risk-based approach.
• Internal Audits: Ensure ongoing compliance and continuous improvement post-transition.

We’re also offering a free 30-minute QMSR readiness consultation to discuss your current QMS alignment, resource planning, and priority gaps before the compliance deadline. Contact us here or email info@theoris.com for more information.

Compliance Date: February 2, 2026

Don’t wait! Schedule your free consultation today at https://www.theoris.com/contact/.