ISO 13485 modernization for the modern medical device maker.

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

Quality management system

QT9 QMS automates workflow with controlled processes.

ISO 13485: 2016 Certification

QT9 QMS helps make ISO 13485 certification and audits a breeze.

Connect & collaborate online

Use supplier & customer portals to involve interested parties in your QMS.

Consistently improve quality

QT9 QMS provides guidance and tools to improve quality.

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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.

Control of Documents

QT9™ QMS Document Control Module

Element 4.2.4

Management Review

QT9™ QMS Management Review Module

Element 5.6

Employee Training

QT9™ QMS Employee Training Module

Element 6.2.2


QT9™ QMS Preventative Maintenance Module

Element 6.3

Risk Management

QT9™ QMS Risk Assessments Module

Element 7.1

Design & Development

QT9™ QMS Engineering Change Request Module

Element 7.3


QT9™ QMS Supplier Evaluation Module

Element 7.4.1

Control of Production

QT9™ QMS Inspection Module

Element 7.5

Monitoring & Measuring

QT9™ QMS Calibration Module

Element 7.6

Customer Feedback

QT9™ QMS Customer Feedback Module

Element 8.2.1

Internal Audits

QT9™ QMS Audit Management Module

Element 8.2.4

Nonconforming Products

QT9™ QMS Nonconforming Product Module

Element 8.3

Corrective Actions

QT9™ QMS Corrective Actions Module

Element 8.5.2

Preventive Actions

QT9™ QMS Corrective Actions Module

Element 8.5.3

Track all your ISO 13485 information in one place.

QT9's easy-to-use ISO 13485 quality management system makes traceability and transparency simple.

Built-In Dashboard

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.

Electronic Signatures

Make approvals electronically with electronic signature capturing built-in. QT9's ISO 13485 quality management system is FDA 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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Talk to a Specialist

Speak directly to a QT9 expert.


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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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