The U.S. Food and Drug Administration (FDA) has finalized one of the most transformative regulatory changes the medical device industry has seen in decades. On February 2, 2026, FDA’s long-standing Quality System (QS) Regulation will be officially replaced by the Quality Management System Regulation (QMSR) a comprehensive update aligning U.S. expectations with ISO 13485:2016.

This shift fundamentally modernizes U.S. device regulation, promotes global harmonization, and elevates expectations for documentation, risk management, and inspection transparency.

For manufacturers preparing for U.S. market entry or maintaining compliance, understanding the QMSR and preparing early is essential.

What Is Changing? Key Highlights of the FDA QMSR

FDA is formally incorporating ISO 13485:2016 by reference, replacing the decades-old QSR (21 CFR Part 820).

This means:

1. U.S. Quality Requirements Now Align with International Standards

Manufacturers operating globally will benefit from:

• Reduced redundancy
• Streamlined compliance across the EU, Canada, Australia, UK, Japan
• Harmonized documentation and risk controls

2. Increased Emphasis on Risk-Based Quality Management

QMSR integrates ISO 13485’s risk-based approach, impacting:

• Design controls
• Supplier oversight
• Production processes
• CAPA management
• Post-market quality data

3. More Transparent FDA Inspection Expectations

FDA investigators will now reference ISO 13485 principles.

However, QMSR retains certain FDA-specific provisions, meaning manufacturers must comply with both:

• ISO 13485:2016
• Unique FDA requirements

What is Catch? New Inspection Access Requirements

One of the biggest changes involves documentation that was historically not subject to FDA review, such as:

• Internal audit reports
• Supplier audit reports
• Management review records

Under QMSR, FDA can now request to see these records.

This is a major cultural and operational shift.
 Manufacturers must ensure:

• Clean audit trails
• Clear decision-making documentation
• Evidence-backed quality processes

Internal documents long treated as “confidential only” must now withstand regulatory scrutiny.

What Manufacturers Should Do Now (2024–2026 Preparation Timeline)

With enforcement in February 2026, companies have limited time to fully transition.

1. Perform a QSR vs ISO 13485 Gap Analysis

Identify:

• Missing documentation
• Process discrepancies
• Gaps in risk management integration
• Supplier oversight deficiencies

2. Update and Strengthen QMS Documentation

Critical areas include:

• Management review structure
• Internal audit process
• Supplier qualification and oversight
• Document control and record retention
• Nonconformance and CAPA traceability

3. Train Quality and Regulatory Teams

Staff must understand:

• New terminology
• FDA’s ISO-aligned expectations
• Expanded inspection access
• Risk-based decision-making

4. Revise Internal Audit Programs

Internal audits should be:

• ISO 13485 aligned
• More systematic and data-driven
• Ready for external review

5. Review of Supplier Audit and Qualification Programs

Expect:

• More detailed traceability
• Stronger documentation justification
• Risk-based supplier performance controls

6. Prepare for FDA Inspection Shifts

Inspections will focus on:

• QMS consistency
• Risk documentation
• End-to-end traceability

7. Use the ANSI IBR Portal for Free ISO 13485 Read-Only Access

FDA recommends the ANSI portal for reviewing the standard.

Why This Change Matters for the Global Market

The FDA’s QMSR transition represents a historic global alignment milestone, offering:

Harmonization

Manufacturers gain a unified regulatory foundation across major markets.

Reduced Duplicate Work

ISO 13485-aligned processes remove redundant documentation between geographies.

Stronger Risk Management

ISO’s risk-centric structure improves product lifecycle safety.

Clearer Expectations for Digital, AI-Enabled, and Complex Devices

Industry evolution requires updated quality frameworks.

For companies already certified ISO 13485, this transition offers a significant advantage.

Industry Impact: Who Will Feel This the Most?

The new QMSR deeply affects:

• Small and medium medical device manufacturers
• Companies entering the U.S. market for the first time
• Firms with legacy QSR-only systems
• OEM–CMO partnerships
• Software and AI-enabled device developers
• Global manufacturers seeking regulatory harmonization

Companies relying heavily on legacy documentation or inconsistent internal systems will need significant transformation to meet QMSR expectations.

Additional Updates to Note (2024–2026 Regulatory Insight)

• QMSR is part of FDA’s broader strategy to modernize medical device oversight.
• FDA continues to increase its focus on risk management, cybersecurity, and supplier qualifications.
• Overlaps with EU MDR/IVDR compliance can reduce overall operational complexity.
• Manufacturers should anticipate updated FDA guidance to support QMSR inspections.

Conclusion

The FDA QMSR is the most substantial modernization of U.S. medical device quality systems in decades. It aligns the U.S. regulatory framework with ISO 13485, reinforces global harmonization, increases transparency, and elevates quality expectations across the entire device lifecycle.

With February 2, 2026, fast approaching, companies must take proactive steps gap analysis, documentation updates, team training, and supplier oversight enhancement to ensure full readiness.

Organizations that prepare early will benefit from:

• Faster inspection readiness
• Fewer compliance gaps
• Stronger global market alignment
• Reduced regulatory risk

How Maven Regulatory Solutions Supports QMSR Transition

Maven Regulatory Solutions provides comprehensive expertise to help manufacturers transition smoothly to the new QMSR requirements.

Our Support Includes:

• QMSR transition strategy and readiness assessment
• ISO 13485 gap analysis and QMS updates
• Internal audit and supplier audit program enhancement
• FDA inspection preparation
• Documentation restructuring and process optimization
• Training for quality and regulatory teams
• End-to-end U.S. market compliance support

Maven ensures manufacturers are fully prepared for the February 2026 enforcement deadline with robust, compliant, audit-ready systems.