---
title: QMSR
canonical: "https://www.qualio.com/qmsr"
updatedDate: "2026-10-26T15:51:16.000Z"
description: ""
---

# QMSR

## 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.

Reduction in audit prep

ROI in 2 months

Lower consultant spend

## 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.

### 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.

## From Gap to Compliant in 3 Steps.

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

### Map your QMS

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

### Gap Analysis in 30 Min

Qualio generates a prioritized gap report and suggests remediation paths.

### Remediate with Guided Workflows

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

## 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.

## See Qualio in Action