21 CFR Part 820 compliance made simple.

21 CFR Part 820 compliance software for the Current Good Manufacturing Practice of the manufacturing and distribution of medical devices. Meet FDA regulations accurately and efficiently with the QT9™ QMS.

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21 CFR Part 820 compliance for the modern medical device manufacturer.

Keep track of medical device compliance items and synchronize documentation with anyone, anywhere.

Track all your 21 CFR Part 820 compliance in one place.

QT9's easy-to-use 21 CFR Part 820 system makes traceability and transparency simple.


Built-In Dashboard

Quickly see the status of 21 CFR Part 820 items with real-time reports from the QT9 dashboard. You can even personalize the view specific to your needs.

Electronic Signatures

Make approvals electronically with electronic signature capturing built-in. QT9's 21 CFR Part 820 quality management system is 21 CFR Part 11 compliant.

Software Validation

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.

Cross-Platform Support

Whether you use Android, iOS or Windows, QT9 works from virtually any web browser.

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Speak directly to a QT9 expert.

1-866-913-5022

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Have questions? Want to discuss solutions?

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Live Demo Request

See a personalized demo of QT9 QMS.

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