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ISO 13485 quality management system for medical device makers. Easily meet FDA regulations accurately and efficiently with the QT9™ QMS.
Keep track of medical device compliance items and synchronize documentation with anyone, anywhere.
QT9 QMS automates workflow with controlled processes.
QT9 QMS helps make certification and audits a breeze.
Use supplier & customer portals to involve interested parties in your QMS.
QT9 QMS provides guidance and tools to improve quality.
QT9's ISO 13485 quality management system is your all-in-one ISO 13485:2016 software solution for medical devices.
QT9™ QMS Document Control Module
QT9™ QMS Management Review Module
QT9™ QMS Employee Training Module
QT9™ QMS Preventative Maintenance Module
QT9™ QMS Risk Assessments Module
QT9™ QMS Engineering Change Request Module
QT9™ QMS Supplier Evaluation Module
QT9™ QMS Inspection Module
QT9™ QMS Calibration Module
QT9™ QMS Customer Feedback Module
QT9™ QMS Audit Management Module
QT9™ QMS Nonconforming Product Module
QT9™ QMS Corrective Actions Module
QT9's easy-to-use ISO 13485 quality management system makes traceability and transparency simple.
Quickly see the status of ISO 13485 items with real-time reports from the QT9 dashboard. You can even personalize the view specific to your needs.
Make approvals electronically with electronic signature capturing built-in. QT9's ISO 13485 quality management system is FDA 21 CFR Part 11 compliant.
QT9 QMS is validated after each release, and it is in line with FDA QSRs to keep you in compliance with FDA quality system requirements.
QT9 lets you choose modules based on what's best for your organization.
With multiple modules to choose from, there's solutions for nearly anyone.
Whether you are a large corporation or a small start-up you can use as many modules as you want.
Whether you use Android, iOS or Windows, QT9 works from virtually any web browser.
Speak directly to a QT9 expert.
Have questions? Want to discuss solutions?
See a personalized demo of QT9 QMS.