QMS Software for European Union Medical Device Regulation (EU MDR)
Simplify EU MDR compliance with a cloud-based QMS built for medical device manufacturing. Manage technical files, risk, CAPAs, audits and training in one platform.
Centralized Document Control
Efficient creation, version control, approval workflows and linking for easy traceability.
Streamlined, Connected Data
Manage and integrate clinical data, PMCF plans and reports for real-time insights and continuous feedback.
Integrated Risk Management
Identify, analyze, evaluate, control and monitor risks, linking them to design and manufacturing processes.
Robust CAPA Processes
Integrated nonconformance and CAPA management with automated root cause analysis.
Get seamless EU MDR compliance with QT9 QMS
QT9 QMS streamlines critical processes, enhances data integrity and ensures audit-readiness for EU medical device regulatory confidence.
QT9 QMS is built for medical device manufacturers
Automated document control
Electronic CAPA system with full traceability
Automate CAPAs tied to complaints, audits or nonconformances. Maintain traceability and link actions directly to risk assessments and quality events.
Training management for role-based compliance
Track employee qualifications and assign training related to SOPs, regulatory changes or product updates. Ensure staff meet MDR-required competencies.
Compliant risk management
Identify, evaluate and mitigate risks with integrated tools that align with ISO 14971 and EU MDR Annex I, including design, production and post-market risk.
Audit management for internal and external reviews
Plan, conduct and document audits, complete with audit trails, findings and follow-ups. Be ready for notified body reviews or EU inspections.
See how QT9 QMS stacks up against EU MDR requirements
QT9 QMS offers validated, cloud-based tools to help medical device manufacturers meet the unique regulatory, operational and quality documentation requirements of EU MDR.
Technical Documentation
QT9 QMS Document Control, Audit Management, Product Design and Risk Management modules
Post-Market Surveillance & Vigilance
QT9 QMS Customer Feedback, CAPA and Risk Management modules
CAPA & Nonconformance
QT9 QMS CAPA Management, Nonconforming Products and Customer Feedback modules
General Safety and Performance
QT9 QMS Risk Management, Document Control, Training and Customer Feedback modules
UDI & Label Control
QT9 QMS Document Management module
Supplier Qualification
QT9 QMS Supplier Surveys and Supplier Evaluations modules, Supplier Portal
Personnel Competency & Training
QT9 QMS Employee Training module
Internal Audits & Inspections
QT9 QMS Audit Management, Inspections and CAPA modules
Clinical Evaluations
QT9 QMS Document Control, Audit Management modules
Conformity Declaration, CE Mark
QT9 QMS Document Control, Audit Management modules
Continuous Improvement
QT9 QMS Preventive Actions and Management Review modules
Product Realisation
QT9 QMS Product Design Controls, Engineering Change Orders and Change Management modules
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.
Unlimited support included
Have a question? QT9 support is here to help for all QT9 QMS users.
FAQ: EU MDR
The EU Medical Device Regulation (EU MDR), Regulation (EU) 2017/745, governs the safety, performance and post-market surveillance of medical devices sold in the European Union. It applies to all manufacturers placing medical devices on the EU market, from Class I to Class III.
EU MDR requires manufacturers to implement a comprehensive quality management system that includes document control, risk management, CAPA, post-market surveillance and procedures for ensuring product safety and performance throughout the device lifecycle.
QT9 QMS offers automated tools for document control, risk management, CAPA, training, audits and more, all aligned with EU MDR requirements. It supports traceability, post-market surveillance and compliance with Annex IX and XI of the regulation.
Yes. QT9 QMS centralizes and manages the documentation required for CE marking and EU MDR technical files, including risk assessments, SOPs, UDI, labeling and post-market data.
Yes. QT9 QMS includes tools to track complaints, nonconformances, CAPAs and audit results, making it easy to collect and analyze post-market surveillance data as required under EU MDR.
Explore more quality management 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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