EU MDR Compliance for
Medical Device Manufacturers
Simplify European Union Medical Device Regulation (EU MDR) compliance with QT9 QMS, supported by QT9 ERP for connected manufacturing and operational data. Manage technical documentation, risk management, CAPA, audits, and training within a unified, cloud-based platform built for medical device companies.
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 and QT9 ERP
lQT9 QMS streamlines quality processes, supported by QT9 ERP for connected data that enhances audit readiness and EU medical device regulatory confidence.
Your QMS, designed for the way medical device manufacturers work
Automated document control
Centralize and version-control documents, procedures and records. Ensure documents tied to your technical file are audit-ready and securely accessible.
Organizations leveraging document automation see up to an 85% reduction in compliance-related errors.
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.
Modern CAPA systems that maintain full audit trails are considered a regulatory best practice in ISO/FDA compliance.
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.
Nearly 8 in 10 organizations now use specialized platforms for compliance training—suggesting role-based training is a mature expectation, not a nice-to-have.
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.
With 78 % of orgs reporting a major security incident yearly, effective risk management isn’t optional. Over half of companies already credit risk management software with reducing operational losses
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.
Automated audit workflows can cut audit prep time by nearly half, freeing up compliance teams from the 9.5 hours/week average burden many now face.
See how QT9 QMS and QT9 ERP stack up against EU MDR requirements
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.
Pre-validated QMS & ERP software
QT9 QMS and QT9 ERP are pre-validated for accelerated compliance.
-
FDA and ISO compliance out-of-the-box
-
Rapid cloud deployment for faster implementation
-
Audit-ready with timeline traceability
-
Electronic signature approvals and secure access controls
-
Continuous validation and updates
|
• ISO 13485 |
• FDA 21 CFR Part 11 |
QT9 includes a complete execution of all protocols, including Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).
-
Eliminates costly internal software validation efforts that can take months of staff time or cost thousands in consultant fees.
-
Reduces downtime waiting for your solution to be approved for use.
-
Minimizes the risk of any failed audits due to flawed validation protocols.
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
ISO 13485 Software Guidelines
FDA 21 CFR Part 820 & ISO 13485 Harmonization for Med Devices
Try QT9 for free
Ready to simplify your quality processes? No credit card needed.