ERP Software for 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 

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

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. 

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

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.

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

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.

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.

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

Both! QT9 ERP offers both on-premise and cloud-based solutions. Customers can choose the platform that works best for them from three options:

1. Desktop Cloud: QT9 ERP is installed on the client’s Windows PC with an internet connection to their data.
2. Web Purchase: Our on-premise solution, where QT9 ERP is installed locally on the client’s web server.
3. Web Subscription: Cloud-based ERP subscription hosted on QT9’s servers and access via the internet and a web browser.

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

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.

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.