ISO 13485 modernization for the modern medical device maker.
Keep track of medical device compliance items and synchronize documentation with anyone, anywhere.
See how QT9™ QMS stacks up against the ISO 13485:2016 standard.
QT9's ISO 13485 quality management system for the medical device industry is your all-in-one ISO 13485:2016 software solution.
Track all your ISO 13485 information in one place.
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™ QMS is flexible for your business.
QT9 lets you choose modules based on what's best for your organization.
Modules for any business size
With multiple modules to choose from, there's solutions for nearly anyone.
A solution that scales with you
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.