QMS Software Medical Device Medical Device QMS Software
Medical Device QMS Software
Simplify ISO 13485 & FDA 21 CFR 820 compliance with cloud-based quality management software built for medical device companies.
End-to-end quality automation for medical devices
- Centralize document control with Part 11-compliant e-signatures
- Automate change control, CAPA and NC tracking
- Manage training assignments and certifications with ease
- Generate audit-ready reports in seconds
- Ensure traceability from design to production
- Simplify supplier management and quality audits
Key features for medical device manufacturers
Document Control
Maintain full version control and electronic approvals.
Design Control
Track design history files (DHFs) and design inputs/outputs.
CAPA Management
Streamline corrective and preventive actions with automated workflows.
Employee Training
Assign and verify training with electronic tracking and reminders.
Change Management
Audit Management
Plan, execute and document internal and external audits.
Risk Management
Track risk using built-in risk management tools
Complaint Handling
Log, investigate and close complaints faster with built-in escalation.
Supplier Quality
Evaluate and track supplier performance in real time.
Built to support international medical device compliance
FDA 21 CFR Part 820
U.S. quality system regulation for medical device manufacturing and distribution
ISO 13485
International quality management criteria for medical device manufacturers
FDA 21 CFR Part 11
U.S. regulations for electronic records and signatures
EU MDR
European Union Medical Device Regulation
MDSAP
Medical Device Single Audit Program
UDI
Unique Device Identification system for tracking medical devices throughout distribution and use
Post-Market Surveillance
Monitor safety and performance of devices after released to market
Pre-validated QMS software
QT9 QMS is pre-validated for accelerated compliance.
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FDA and ISO compliance out-of-the-box
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Rapid cloud deployment for faster implementation
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Audit-ready with timeline traceability
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Electronic signature approvals and secure access controls
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Continuous validation and updates
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• ISO 13585 |
• FDA 21 CFR Part 11 |
QT9 QMS includes a complete execution of all protocols, including Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).
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Eliminates costly internal QMS validation efforts that can take months of staff time or cost thousands in consultant fees.
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Reduces downtime waiting for your QMS to be approved for use.
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Minimizes the risk of any failed audits due to flawed validation protocols.
QT9™ QMS is flexible for your business.
QT9 lets you choose modules based on what's best for your organization.
Modules for any business size
With multiple modules to choose from, there's solutions for nearly anyone.
A solution that scales with you
Whether you are a large corporation or a small start-up you can use as many modules as you want.
Cross-Platform Support
Whether you use Android, iOS or Windows, QT9 works from virtually any web browser.
FAQ: Medical Device QMS
A medical device quality management system (QMS) is a formalized set of business processes that documents the policies and procedures a medical device company must use to ensure their products are safe, effective and in compliance with all applicable regulations and standards.
Medical device QMS software automates quality management processes and documentation and unites them into one, dedicated and integrated software solution that affords greater productivity and collaboration. A medical device eQMS improves the overall efficiency of operations by providing a built-in framework for quality and compliance where tasks are automated, data is available in real time, and controls are easily managed.
With QMS software, medical device development, design and manufacturing quality management processes are completely automated and connected, reducing the opportunity for human error and keeping quality tasks on track. QMS software is geared toward compliance, making necessary compliance tasks a part of everyday work. Some of the features of medical device QMS software include:
- Document Control
- Design Management
- Change Control
- Customer Complaints
- Audit Management
- Engineering Changes
- Employee Training
- CAPA/Nonconforming Products
- Supplier Management
QMS software provides efficiencies that help your business work smarter, such as automated document management with electronic signatures, built-in traceability, task and scheduling reminders, and access at any time, from anywhere
Medical device companies are required to adhere to strict laws, regulations and standards. The International Organization for Standardization (ISO) has established standards that medical device companies must follow. ISO 13485: 2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
The Food and Drug Administration (FDA) has established current good manufacturing practice (cGMP) requirements for medical device quality management systems in the United States. FDA 21 CFR Part 820 requirements, also known as Quality System Regulation (QSR) detail the requirements of the quality management system for medical device companies.
Beginning February 2, 2026, the U.S. FDA requirements for medical device quality management systems will more closely align with the international consensus standard for Quality Management Systems for medical devices (ISO 13485) used by many other regulatory authorities around the world. The revised FDA 21 CFR Part 820 requirements are called the Quality Management System Regulation (QMSR).
QT9 QMS offers an end-to-end solution for addressing the challenges of compliance and quality management in the medical device industry. QT9 QMS offers more than 25 modules that come standard, including:
- Document Control
- Risk Management
- Audit Management
- Employee Training
- Supplier Management
- Customer Feedback
- Product Design Controls
QT9 also offers the ability for medical device companies to create electronic Device History Records (eDHR) and Device Master Records (eDMR) with one click using a simple QT9 QMS and QT9 ERP integration. Take advantage of QT9’s free validation and a dedicated compliance portal for securely sharing DHR and DMR records with auditors.
QT9 QMS is a fully validated, highly rated eQMS that is cost effective, easy to use and offers full customer support, an available ERP integration and Business Intelligence tool. QT9’s user-friendly interface and no-nonsense licensing lets medical device companies focus on getting quality, life-changing products to market faster.
Why medical device companies choose QT9
QT9 has streamlined our internal auditing process, preparation for regulatory audits, document control and approval, and organizational training. We have been able to reduce our active documents by 30% as unnecessary/redundant documents and procedures have been made more visible through the document review process.
Small-Business (11-50 emp.)
The document control feature has improved our ability to find documents and some records when requested for audit or project purposes. Training is much easier to manage. I like being able to link equipment and gages to system documentation in the Document list. The customer service has always been helpful and responds quickly.
Mid-Market (51-200 emp.)
We are a medical device company and myself, the FDA & ISO auditors liked the traceability, control of documents and everything was there at our fingertips from Management review to Documents to CAR's. QT9 is always responsive to our questions and resolving issues. For the cost, the flexibility, electronic signature and traceability is worth trying out the system.
Director of QA/RA
Explore QMS resources
From Concept to Market: FDA Approval Process for Medical Devices
Boost Medical Device Development with Design Control Software
10 Tips for Optimizing Your Medical Device Quality Management System
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