ERP for medical device companies
QT9™ ERP is geared toward ISO 13485 and FDA 21 CFR Part 820 compliance, including FDA 21 CFR Part 11 electronic signatures. QT9 ERP is an intuitive platform with one-click electronic Device Master Record (eDMR) and electronic Device History Record (eDHR) capability, record traceability, and inventory control with barcoding for the medical device industry.

MEDICAL DEVICE ERP VALIDATION
Validation made easy
Need to validate your ERP solution? QT9 ERP handles your validation for you - saving you precious time and money. Get a quote or sign up for a live demo today.
Why QT9 ERP for medical devices?
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QT9 ERP is fully-validated with IQ, OQ, PQ validation reports included for free with every version upgrade.
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QT9 ERP is a trusted ERP for medical device companies, offering complete approval processes for device master records, sales orders, purchase orders and jobs.
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QT9 ERP helps control the release of inventory through approval processes.
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With QT9 ERP you can verify steps in manufacturing processes with electronic signature approvals.
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Integrate Bill of Materials and Jobs applications with controlled documents from QT9 QMS.
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Integrate purchasing and manufacturing with electronic inspections in QT9 QMS.
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Incorporate unlimited file attachments to compliance records - including Device History Records (DHRs).

Connect every team in your medical device business
Get better bill of material management, inventory alerts and even links to quality management software.
eDMR and eDHR Capability
- One-click print eDMR and eDHR
- Compliance Portal for auditors
- Eliminate paper processes
Automate Compliance
- Integrates to QT9 Quality Management Software
- Software validation included
- Support ISO 13485 and FDA standards
Control Inventory
- Expiring inventory alerts
- Lot and serial traceability
- Barcode inventory for accuracy
Improve Operations
- Bill of Material revision control
- Visualize production scheduling
- Shop floor management
Reporting & Analytics
- Filter, summarize and export data
- Performance dashboards
- Custom reporting
Purchasing & Planning
- Reorder points and lead times
- MRP and forecasting capability
- PO inspections and approvals
QT9 ERP seamlessly integrates with QT9's quality management software suite
Automatically sync your suppliers, customers and products across QT9 ERP and QT9 QMS and experience a unified system for managing quality and business operations.
Non-Conformance & CAPA Management

Non-conformance and CAPA management
Nonconforming product records and corrective actions can be created in QT9 QMS right from event-driven actions in QT9 ERP. These include PO receiving, inspection and history, as well as from the Jobs/Manufacturing and customer sales and service areas. By giving users the ability to create non-conformance and CAPA records from the ERP, there is full data transfer and permanent linking to your QMS records in the ERP, saving time and maintaining historical data about quality actions in your ERP.
Supplier & Vendor Management

Supplier and vendor management
QT9 ERP maintains supplier records, while QT9 QMS tracks supplier quality performance and audits. Supplier-related nonconformances, engineering changes, audits and other quality processes in QT9 QMS sync with vendor records in QT9 ERP to ensure compliance.
Document Control & Revision Management

Document control and revision management
QT9 QMS document control links with QT9 ERP to ensure only approved, up-to-date documents (e.g., SOPs, work instructions) are accessible for production, engineering and quality teams.
QT9 QMS documents can be approved as part of QT9 ERP Bill of Materials and enable seamless passthrough to the Shop Floor Manager. This gives production-floor employees access to the latest approved work instructions and other controlled documents.
Production & Purchasing Inspections

Production and purchasing inspections
Work orders and production processes in QT9 ERP can create quality inspections in QT9 QMS, transferring the proper manufacturing data to the inspection record.
PO receiving can generate the proper QT9 QMS inspection record for your supplier and material-specific inspections.
Customer Complaints & Returns (RMA Process)

Customer complaints and returns (RMA process)
Customer returns in QT9 ERP have the ability to generate customer complaints and feedback records in QT9 QMS, creating a seamless customer service and quality experience.
Root cause analysis in QT9 QMS feeds into ERP adjustments for inventory, production and supplier performance.

Non-conformance and CAPA management
Nonconforming product records and corrective actions can be created in QT9 QMS right from event-driven actions in QT9 ERP. These include PO receiving, inspection and history, as well as from the Jobs/Manufacturing and customer sales and service areas. By giving users the ability to create non-conformance and CAPA records from the ERP, there is full data transfer and permanent linking to your QMS records in the ERP, saving time and maintaining historical data about quality actions in your ERP.

Supplier and vendor management
QT9 ERP maintains supplier records, while QT9 QMS tracks supplier quality performance and audits. Supplier-related nonconformances, engineering changes, audits and other quality processes in QT9 QMS sync with vendor records in QT9 ERP to ensure compliance.

Document control and revision management
QT9 QMS document control links with QT9 ERP to ensure only approved, up-to-date documents (e.g., SOPs, work instructions) are accessible for production, engineering and quality teams.
QT9 QMS documents can be approved as part of QT9 ERP Bill of Materials and enable seamless passthrough to the Shop Floor Manager. This gives production-floor employees access to the latest approved work instructions and other controlled documents.

Production and purchasing inspections
Work orders and production processes in QT9 ERP can create quality inspections in QT9 QMS, transferring the proper manufacturing data to the inspection record.
PO receiving can generate the proper QT9 QMS inspection record for your supplier and material-specific inspections.

Customer complaints and returns (RMA process)
Customer returns in QT9 ERP have the ability to generate customer complaints and feedback records in QT9 QMS, creating a seamless customer service and quality experience.
Root cause analysis in QT9 QMS feeds into ERP adjustments for inventory, production and supplier performance.
Simplify medical device traceability
Streamline how medical device manufacturers share, access and collaborate across roles, departments and locations. QT9 ERP, a trusted ERP for Medical Device Companies provides a central place to know who worked on what and when, with FDA 21 Part 11 electronic signature approvals and transactional audit trails.


Digitize medical device quality workflows
Don't get bogged down with time-consuming, redundant tasks. No matter where your team works, QT9 ERP can automate it for you to deliver high-quality, safe products consistent with Good Manufacturing Practices (GMP). Integration with our industry leading QT9 Quality Management Software (QMS) gives you one, single platform for your medical device manufacturing business.
Protect against recalls
QT9 ERP helps minimize risk by enabling you to control every revision of your Bill of Materials, so you know who ordered what, when it was manufactured and exactly what materials went into it. As an ERP for Medical Device Companies, QT9 ERP helps streamline traceability and simplifie the process of locating recall information in seconds rather than days.

Medical Device ERP FAQs
How does an ERP system benefit medical device manufacturing?
By integrating various business processes into a single platform, ERP systems help medical device manufacturers reduce errors, improve data visibility and accelerate time to market—all while maintaining a high level of quality and safety. Other benefits include:
- Improved productivity by automating and integrating routine tasks
- Streamlined regulatory compliance by ensuring accurate record keeping, automating reporting and providing built-in audit trails
- Real-time data for faster, better analysis and decision-making
- Better risk management by eliminating information silos and providing better insight into resources and operational processes
- Simplified collaboration as everyone is working from one, unified system
- Stronger data security
- Cost savings from streamlined processes and fewer redundant activities
What ERP features are most useful for medical device manufacturers?
Medical device manufacturers will benefit from all ERP applications, such as accounting, purchasing and manufacturing management. Other features important to medical device manufacturing include:
- Electronic Device Master Record/Device History Record (eDMR/eDHR) creation and maintenance
- Barcoding and scanning to efficiently track inventory, equipment, labor and jobs
- Lot and serial traceability for inventory management and use in the event of a recall
- Advanced inventory controls to optimize stock levels, track locations, automate reorders and analyze data
- Bill of Materials (BOM) management
- Supplier management
- Inspections
- Electronic signature approval capabilities
Can medical device ERP software help with regulatory compliance?
Absolutely. Most ERP systems come with built-in compliance features that help meet industry and government regulations by ensuring accurate record-keeping, automating reporting and providing built-in audit trails. Features such as electronic device records ensure that a device manufacturer maintains and can easily demonstrate compliance. This reduces the risk of noncompliance penalties and streamlines the process of adhering to standards.
QT9 ERP also seamlessly integrates with QT9 QMS quality management software, which provides additional regulatory applications, such as document control and corrective and preventive actions (CAPA) management.
What regulatory standards are supported by a medical device ERP?
Medical device regulations ensure the safety and efficacy of devices by requiring manufacturers demonstrate suitability for the intended use. The most referred to regulations include:
- ISO 13485:2016 –international quality management system standards
- FDA 21 CFR Part 820 – the U.S. Food and Drug Administration’s current Good Manufacturing Practice (cGMP), which will become the Quality Management System Regulation (QMSR) in February 2026
- EU MDR 2017/745 – medical device regulations in the European Union
- SOR/982-282 – Canada’s medical devices regulations
Is the ERP system validated or does it support validation?
Yes, QT9 ERP is fully validated and provides free continuous validation. This means that QT9 ERP has already rigorously tested and documented that our ERP performs as intended and meets FDA 21 CFR Part 11, Part 211 and Part 820 regulatory requirements, and is ISO 9001 and ISO 27001 certified.
How does the ERP support risk management and traceability?
QT9 ERP software supports risk management and traceability through an integrated suite of tools designed to streamline and integrate processes and data accuracy, and enhance visibility across operations. More specifically, QT9 ERP offers:
- Batch, lot and serial number tracking
- Integrated inventory control
- Supplier management applications
- End-to-end traceability
- Seamless integration with QT9 QMS software
What are QT9 ERPs integration capabilities?
In addition to full integration between business processes through its applications, QT9 ERP offers seamless integration with QT9 QMS quality management software, which offers end-to-end regulatory and quality compliance tools, such as document control and CAPA management.
QT9 ERP also offers easy integration of its Business Intelligence tool, which provides advanced analytic capabilities that help manufacturers identify trends and optimize performance.
Can QT9 ERP handle multi-site, multi-country operations?
Yes, QT9 ERP provides a multi-site, multi-company architecture designed to connect data, users and operations across locations, departments or companies. Manage global initiatives from anywhere and be more productive and consistent across operations.
Is QT9 ERP scalable?
QT9 ERP is highly scalable, designed to easily grow with your business’ needs, whether they be growth, expansion or increased data volume. Our cloud-based architecture offers:
- Unlimited data
- 17+ integrated applications
- Ability to adopt applications as needed
- Easy addition of more users and locations
- Global accessibility
Is QT9 ERP available in the cloud or on-premise?
Both! QT9 ERP offers both on-premise and cloud-based solutions. Customers can choose the platform that works best for them from three options:
- Desktop Cloud: QT9 ERP is installed on the client’s Windows PC with an internet connection to their data.
- Web Purchase: Our on-premise solution, where QT9 ERP is installed locally on the client’s web server.
- Web Subscription: Cloud-based ERP subscription hosted on QT9’s servers and access via the internet and a web browser.
What type of training and support is included?
QT9 offers award-winning support services, including:
- Unlimited training, from onboarding to refreshers
- Unlimited support, including implementation and software optimization
- QT9 ERP Help Center, self-service support available 24/7
- Fully validated platform
- Free software updates
- Professional services for accounting and operations
What kind of reporting or dashboard analytics are available?
QT9 ERP seamlessly integrates with the QT9 Business Intelligence (BI) tool, which transforms complex data into more user-friendly visualizations that make it easier to uncover insights and optimize performance. Drag-and-drop functionality makes it easy to create customized dashboards and reports from real-time data.
Why choose QT9 ERP as your total enterprise solution?
QT9 ERP is a comprehensive system that can work for any size company, improving efficiency and accuracy through integrated data and automated operations.
QT9 ERP provides more than 17 modules as part of its standard offering, as well as easy access to data and analytics to help businesses make the best decisions for moving forward.
With QT9 ERP you get:
- 17+ modules, including eDHR/eDHF
- Customer, compliance, supplier and physical inventory web portals
- Lot and serial number tracking and inventory control
- Tailored customer support
- Real-time reporting with mobile accessibility
- Seamless integration with QT9 QMS quality and compliance software
Reach out today for a demonstration or to get started with a free trial.
Experience QT9 ERP in action today
Schedule your personalized demo and start a free trial.