QMSR (Quality Management System Regulation)
Connect and centralize your QMSR compliance processes with QT9 QMS, the connected quality management software built to simplify FDA quality system requirements, strengthen product safety and effectiveness and support continuous compliance across the product lifecycle. QT9 QMS helps organizations transition to and maintain alignment with the FDA’s Quality Management System Regulation, harmonized with ISO 13485, while reducing risk, improving visibility and streamlining regulatory readiness.
Optimize Quality Workflows
Automate design controls audits CAPA and change management to keep your quality system proactive instead of reactive and fully aligned with QMSR requirements.
Improve Operational Efficiency
Eliminate manual paperwork and reduce delays by managing all QMSR-related quality activities in one connected quality management system.
Centralize Quality Data
Gain real-time visibility across teams with centralized documentation records and reporting to ensure every quality process remains aligned with FDA QMSR expectations.
Drive Continuous Improvement
Track quality trends identify risks and implement corrective actions faster to support ongoing improvement regulatory readiness and product safety.
Automate QMSR quality management processes
Eliminate outdated paper-based quality system processes that are error-prone and inefficient. With QT9 QMS, you can replace manual checklists, disconnected spreadsheets and fragmented records with a unified digital platform that supports QMSR compliance by managing design controls, risk management, document control, audits, CAPA and more within a single connected system.
Explore how QMSR software can benefit your organization
Strengthen product quality and regulatory efficiency
Improve workflow automation and ensure full traceability of design quality manufacturing and post-market quality records across the entire product lifecycle.
Simplify FDA QMSR compliance
Support adherence to FDA Quality Management System Regulation requirements by automating document control risk management audits and CAPA workflows to reduce compliance risk.
Streamline FDA audits and inspections
Prepare for FDA inspections more efficiently by automating audit scheduling tracking and reporting of QMSR-related quality data in one centralized system.
Reduce quality risk cost and rework
Lower the risk of nonconformances recalls and production inefficiencies by improving visibility into quality performance and responding proactively.
Improve cross-functional collaboration and accountability
Promote a culture of quality by improving communication across teams ensuring accountability and resolving quality issues faster.
Align QMSR compliance with your quality management workflows
QT9 QMS provides a structured digital framework for FDA Quality Management System Regulation (QMSR) compliance aligning automated workflows directly with 21 CFR Part 820 and its harmonization with ISO 13485. Explore how each QT9 QMS module supports specific QMSR requirements to help you maintain control consistency and inspection readiness across your quality system.
See how QT9 supports FDA QMSR compliance
Below are key requirements of the FDA Quality Management System Regulation (21 CFR Part 820) and how QT9 QMS modules align with them helping you connect your quality system to QMSR expectations and drive continuous improvement across the product lifecycle.
General QMS Requirements
QT9 QMS Document Control & Employee Training Modules
Documentation Requirements
QT9 QMS Document Control Module
Management Commitment
QT9 QMS Managment Review Module & Responsible Parties
Customer Focus
QT9 QMS Customer Web Portal & Customer Feedback Modules
Quality Policy
QT9 QMS Risk Managment & Management Review Modules
Responsibility & Authority
QT9 QMS Employee Training & Management Review
Provision of Resources
QT9 QMS Document Control and Employee Training Modules
Infrastructure
QT9 QMS Calibration Management & Preventive Maintenance Modules
Planning of Product Realization
QT9 QMS Risk Management Module
Customer-Related Processes
QT9 QMS Customer Web Portal
Design & Development
QT9 QMS Product Design Controls Module
Production & Service Provision
QT9 Validation & Traceability
Control of Monitoring & Measuring Equipment
QT9 QMS Calibration Managment Module
Monitoring & Measurements
QT9 QMS Customer Feedback, Audit Managment & Calibration Managment Modules
Control of Nonconforming Product
QT9 QMS Nonconforming Products Module
Improvement (CAPA)
QT9 QMS Corrective & Preventive Actions Module
Unlimited Training Included
Accelerate your organization's growth with unlimited training for all QT9 QMS users.
FAQ: QMSR
The FDA Quality Management System Regulation replaces the former Quality System Regulation and aligns 21 CFR Part 820 with ISO 13485. QMSR establishes requirements for quality management systems used in the design manufacturing and distribution of medical devices in the United States.
The FDA Quality Management System Regulation becomes effective on February 2, 2026. Medical device manufacturers must ensure their quality management systems are updated and compliant by this date to avoid regulatory risk.
QMSR harmonizes FDA requirements with ISO 13485 by incorporating the ISO standard by reference. While some FDA-specific requirements remain QMSR reduces duplication for organizations already certified to ISO 13485 and supports global regulatory alignment.
QMSR does not require organizations to obtain ISO 13485 certification. However quality management systems must meet ISO 13485 requirements as incorporated into the FDA regulation along with FDA-specific provisions.
QT9 QMS provides connected digital workflows for document control design controls risk management CAPA audits training and change management helping organizations align quality processes with QMSR requirements and maintain inspection readiness.
The FDA QMSR applies to medical device manufacturers and other organizations subject to FDA medical device regulations including companies that design produce store or distribute medical devices intended for the US market.
Explore QT9 QMS quality and compliance resources
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