ERP for medical device manufacturers

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 Software

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?

  • QT9 ERP is fully-validated with IQ, OQ, PQ validation reports included for free for every version upgrade.

  • Our ERP includes complete approval processes for device master records, sales orders, purchase orders and jobs

  • We help you control the release of inventory through approval processes.

  • With QT9 ERP you can verify steps in manufacturing processes with electronic signature approvals.

  • Integrate Bill of Materials and Jobs with controlled documents from QT9 QMS.

  • Integrate purchasing and manufacturing with electronic inspections in QT9 QMS.

  • Incorporate unlimited file attachments to compliance records - including DHRs.

Medical Device ERP Software Solution

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

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

Simplify medical device traceability

Streamline how medical device manufacturers share, access and collaborate across roles, departments and locations. QT9 ERP provides a central place to know who worked on what and when, with FDA 21 Part 11 electronic signature approvals and transactional audit trails.

Medical Device ERP Software
Medical Device ERP Software Digitalization

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. Find recall information in seconds rather than days.


Frequently asked questions

Can I get started with QT9 ERP for free?

Try QT9 ERP for free, no credit card is required. Get started with a free demo on the features if you choose. 

Can I use QT9 ERP for onboarding suppliers?

Yes! Take advantage of the free supplier web portal to get started. 

How can QT9 ERP help manage growth?

QT9 ERP makes it easy to manage growth with a cloud-based platform offering unlimited scalability. Explore the platform in greater depth.