21 CFR Part 820 and QMSR Compliance Consulting

The QMSR Transition, Handled

On February 2, 2026, FDA replaced the Quality System Regulation with the QMSR and retired its old QSIT inspection approach. Most established device quality systems are substantially aligned already, but terminology, documentation structure, and specific clauses changed, and FDA investigators now inspect against the new framework, with authority to review records like management review and audit reports that the old regulation exempted. We run QMSR transition gap assessments that compare your existing quality system against the new requirements, then close the differences with your team.

• QMSR transition gap assessments
• Comparative analysis of QSR-era documentation
• Terminology and structure updates to existing QMS
• Preparation for QMSR-era FDA inspections

Device Quality Systems Built Right

Whether you are standing up your first device QMS or tightening an established one, we support device companies with quality management system development, design controls, risk management, and production process validation. Every system we build is designed to hold up under real regulatory scrutiny, from MDSAP audits to FDA inspections, and we stay through implementation so it works in practice on your floor. For the regulation itself, see FDA's official QMSR page.

• Quality management system development
• Design controls and design documentation
• Risk management aligned with ISO 14971
• Production process validation
• MDSAP and FDA inspection preparation
• CAPA and supplier control programs

Los Angeles Based, Working Nationwide

We are headquartered in Los Angeles and work onsite with device manufacturers across Southern California and statewide, with remote consulting available across the United States. Because the QMSR is built on ISO 13485, this work pairs naturally with our ISO 13485 and ISO 14971 consulting, and inspection preparation is available through our GMP inspection readiness services. See everything we do on our services page.

21 CFR 820 and QMSR Questions

What is the QMSR?

The Quality Management System Regulation is FDA's updated quality regulation for medical devices. Effective February 2, 2026, it amended 21 CFR Part 820 to incorporate ISO 13485:2016 by reference, harmonizing FDA's device quality requirements with the international standard while keeping FDA-specific requirements such as records and labeling controls.

What is the difference between the QSR and the QMSR? Is 21 CFR Part 820 going away?

No. Part 820 still exists, but it was amended and retitled. The former Quality System Regulation is now the QMSR, and its core requirements come from ISO 13485:2016, incorporated by reference.

Do we need ISO 13485 certification to comply with the QMSR?

No. FDA requires compliance with the regulation, not a certificate. Certification remains voluntary and is typically pursued for international markets and customer requirements. Because the QMSR is built on ISO 13485, one well-built quality system can satisfy both.

What should QSR-era quality systems do now?

Run a QMSR transition gap assessment. Most established systems are substantially aligned, but terminology, documentation structure, and specific clauses differ. A comparative analysis shows exactly where your system stands and what needs to change.