Effective February 2, 2026 — ACT NOW

The FDA QMSR
Is Live.
Is Your QMS Ready?

The FDA's new Quality Management System Regulation harmonizes 21 CFR Part 820 with ISO 13485. Qualio's AI-powered platform closes your gaps in weeks — not months.

80%
Reduction in audit prep
5×
ROI in 2 months
60%
Lower consultant spend
See how it works → Learn about QMSR
QMSR Quality Management System Regulation Dashboard
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What Is the FDA QMSR?

The Quality Management System Regulation (QMSR), codified in 21 CFR Part 820, became effective on February 2, 2026. It harmonizes the FDA's device quality requirements with ISO 13485:2016, the international standard for medical device quality management systems.

Under QMSR, FDA now has authority to inspect management review records, internal audit reports, and supplier audit outputs.

Built for QMSR. Not Retrofitted.

Automated Gap Analysis

Qualio cross-maps your documents and processes against all QMSR clauses, surfacing gaps with evidence citations — not just checklists.

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Visibility across all requirements

See your global compliance against QMSR and related requirements like ISO 13485 and MDSAP at a glance.

Continuous Monitoring

QMSR isn't a one-time project. Qualio monitors your compliance posture continuously — alerting your team to drift and gaps before they become observations.

How It Works

From Gap to Compliant in 3 Steps

No implementation sprints. No consultant dependency. Qualio's guided workflow takes you from connection to compliance — fast.

1

Map your QMS

Qualio consolidates all your SOPs, procedures, and objective evidence against QMSR requirements.

2

Gap Analysis in 30 Min

Qualio generates a prioritized gap report and suggests remediation paths.

3

Remediate with Guided Workflows

Assign owners, due dates, and get guided support on fixing gaps.

★ ★ ★ ★ ★
"Qualio gives us a 360° view of our QMS and automatically surfaces the gaps. We resolve issues faster, our team is more productive, and our risk is lower. With the system analyzing our documents and evidence end to end, we know we have full coverage and can walk into audits with total confidence."
S
Christophe Dohr
Site Quality Manager, Sentec
Read Case Study →
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FAQ

QMSR Questions, Answered

When did the QMSR take effect?

February 2, 2026.

Does ISO 13485 certification mean I'm FDA-compliant under the QMSR?

No. ISO 13485 puts you in a strong position, but the QMSR includes FDA-specific requirements, particularly in 820.35 (record control) and 820.45 (labeling and packaging), that go beyond ISO 13485. You need to meet both.

Are FDA definitions still used under the QMSR?

Yes. FDA definitions for terms like "device," "labeling," and "combination products"  take precedence over ISO definitions where there is any conflict.

Get the Free QMSR Compliance Checklist

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