QMSR (Quality Management System Regulation)
Connect and centralize your QMSR compliance processes with QT9 QMS, supported by QT9 ERP for connected operational data. Together, they help simplify FDA quality system requirements, strengthen product safety and effectiveness, and support continuous compliance across the product lifecycle.
QT9 QMS enables organizations to transition to and maintain alignment with the FDA’s Quality Management System Regulation, harmonized with ISO 13485, while QT9 ERP enhances visibility into manufacturing and operational activities, helping reduce risk, improve oversight, and streamline regulatory readiness.
Optimize Quality Workflows
Automate design controls, audits, CAPA and change management to keep your quality system proactive 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 Processes
Eliminate outdated, paper-based quality system processes that are inefficient and prone to error. With QT9 QMS, supported by QT9 ERP for connected operational data, 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 across a connected environment.
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 ISO 13485.
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. Supported by QT9 ERP for connected operational data, QT9 helps you align quality processes with QMSR expectations and drive continuous improvement across the product lifecycle.
QT9 is available in the cloud or on-premise
Flexible deployment to match your IT strategy without compromising security or speed.
Work smarter with intelligent automation in quality and compliance
QT9 Software’s built-in automation streamlines compliance workflows, quality checks, and alerts, reducing human errors, accelerating decision-making and freeing your team to focus on higher-value work.
Speed up implementation with pre-validated software
QT9 Software offers a fully pre-validated environment, with every module and feature tested and documented for compliance. Save time, avoid costly internal validation processes and go live faster with confidence.
Ensure audit-ready traceability across all processes
Track every action, change and event in real time with QT9 Software. Timeline-based traceability supports inspections, audits and product recalls by providing complete visibility into your processes and product history.
Empower teams with secure, self-service portals
QT9 Software provides dedicated web portals for employees, suppliers and customers, enabling secure self-service access to documentation and data while streamlining collaboration across your organization.
Catch and resolve issues instantly with real-time monitoring
Monitor operations live with real-time dashboards and automated alerts using QT9 Software. Enable proactive responses to nonconformances, minimize downtime and improve compliance outcomes across your organization.
Onboard faster with an intuitive, user-friendly platform
Whether you’re a startup or an enterprise, QT9 Software’s clean, intuitive interface minimizes the learning curve, empowering users to work confidently, complete tasks accurately and stay audit-ready from day one.
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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