Streamline ISO 13485 Compliance with QT9 ERP for Medical Devices
Achieve and maintain ISO 13485 certification and stay FDA audit-ready with QT9 ERP’s centralized quality management system for medical device manufacturers. Connect customer complaints, nonconformances and corrective actions in one integrated platform for faster resolution and improved compliance.
Key Benefits of QT9 ERP for Medical Device Companies:
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Centralize customer feedback and quality data for easy access and faster resolution
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Link corrective actions directly to complaints and nonconformance reports (NCRs)
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Launch investigations instantly with one click from any record
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Generate audit-ready reports in real time to simplify ISO 13485 and FDA compliance audits
Ensure FDA 21 CFR Part 820 & CGMP Compliance with QT9 ERP
QT9 QMS helps medical device manufacturers streamline FDA 21 CFR Part 820 requirements and maintain Current Good Manufacturing Practice (CGMP) compliance. With integrated quality and compliance modules, you can manage everything from electronic approvals to calibration and inspections in one centralized ERP system.
Compliance Features Built for FDA-Regulated Manufacturers:
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Secure, FDA 21 CFR Part 11–compliant eSignatures ensure validated approvals across all records
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Track management responsibility and employee training to maintain compliance documentation effortlessly
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Automate audit preparation with built-in document control and purchasing workflows
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Manage inspections and production processes centrally to reduce errors and improve traceability
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Maintain calibration and test records electronically for instant access during audits
Manage eDHR, eDMR & DHF Records in One Centralized System
QT9 ERP makes it easy for medical device companies to manage electronic Device History Records (eDHR), electronic Device Master Records (eDMR), and Design History Files (DHF) across the entire organization. By connecting data across sites, suppliers, and customers, QT9 delivers complete traceability at every stage of production.
Key Capabilities for Medical Device Traceability:
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Centrally connect quality and compliance records across multiple facilities and teams
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Maintain a complete electronic timeline of changes for full visibility and audit trails
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Share controlled documents instantly with suppliers, auditors, and internal teams
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Stay audit-ready for ISO 13485, FDA 21 CFR, and customer-specific compliance requirements
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Generate multi-level eDHR and eDMR records instantly with one click
Integrated CAPA and Non-conformance Management
QT9 ERP and QMS work together to simplify nonconformance management and Corrective and Preventive Actions (CAPA). Users can create nonconforming product records and CAPA events directly from ERP activities — including purchase order receiving, inspections, production jobs, customer sales and service events.
By connecting ERP and QMS in a single system, QT9 ensures:
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Automatic data transfer between ERP events and QMS records
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Permanent traceability of all corrective and preventive actions
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Faster issue resolution with event-driven CAPA creation
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Comprehensive audit history that maintains quality and compliance data long term
Supplier and Vendor Management for Medical Device Compliance
QT9 ERP and QMS give manufacturers a complete supplier quality management solution. While QT9 ERP maintains centralized supplier and vendor records, QT9 QMS tracks supplier performance, audits, nonconformances, and engineering changes — all fully linked back to ERP vendor records.
Benefits of Integrated Supplier Management:
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Monitor supplier quality performance with audit and nonconformance tracking
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Ensure compliance with ISO 13485, FDA 21 CFR and customer requirements
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Centralize vendor records and quality processes in one connected ERP/QMS system
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Reduce risk and improve traceability by linking supplier quality data directly to vendor records
Document Control and Revision Management
QT9 QMS integrates with QT9 ERP to provide a complete document control and revision management system for medical device manufacturers. Only approved and up-to-date documents — including SOPs, work instructions, and quality procedures — are made accessible to production, engineering and quality teams.
How QT9 Improves Compliance & Efficiency:
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Maintain ISO 13485 and FDA 21 CFR compliance with centralized control of all documents
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Link controlled documents to ERP Bills of Materials to ensure accuracy in production
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Deliver the latest approved work instructions directly to the shop floor through seamless ERP integration
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Provide employees with real-time access to SOPs, forms, and controlled documents across departments
Production and Purchasing Inspections
QT9 ERP integrates with QT9 QMS to automate quality inspection management across production and purchasing. Manufacturing work orders and production processes in QT9 ERP can automatically generate inspection records in QT9 QMS, ensuring the correct manufacturing data is transferred and documented.
For purchasing, PO receiving creates supplier- and material-specific inspection records, giving you full traceability from vendor delivery through production.
Key Benefits:
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Standardize inspection processes across production and purchasing workflows
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Maintain compliance with ISO 13485 and FDA 21 CFR requirements
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Ensure complete traceability by linking inspections to work orders and supplier records
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Reduce errors and save time with automated record creation in one connected ERP/QMS system
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
PIC/s
Pharmaceutical Inspection Co-operation Scheme
Integrated QMS, ERP & MRP for 2026 Manufacturing
Optimizing Bill of Materials in Life Sciences ERP
