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.
Frequently Asked Questions: ISO 13485
What is ISO 13485?
ISO 13485 is the international standard outlining the quality management criteria medical device manufacturers must meet to demonstrate compliance with regulatory requirements. Developed by the International Organization for Standardization (ISO), compliance with ISO 13485 demonstrates a company’s commitment to ensuring the consistent safety, effectiveness and compliance of its medical devices.
ISO 13485:2016 is the latest iteration of the 13485 standard and is the version currently used for compliance purposes. ISO standards are reviewed every five years to ensure relevance to the current market.
ISO 13485 certification is a voluntary process that requires an organization’s quality management system to pass a third-party Medical Device Single Audit Program (MDSAP) audit. Being officially certified for ISO 13485 demonstrates to customers and regulators that your medical device products reliably meet stringent quality standards.
Is ISO 13485 mandatory?
ISO 13485 is not mandatory in the United States; however it is mandatory in several other countries, including most of Europe, Canada, Japan and Australia. The U.S. FDA also recently published a final rule amending its medical device quality requirements to bring them more in line with ISO 13485, effective February 2026. Read more about this change here.
What is the difference between ISO 13485 vs. ISO 9001?
ISO 13485 is a quality standard specific to medical devices. It is based on the more general quality management standard of ISO 9001, however ISO 13485 is a more stringent guideline with a greater focus on patient safety. The major differences between ISO 13485 and ISO 9001 include:
- Framework for implementing risk management procedures
- Rigorous document control throughout product lifecycle
- Greater environmental safety and prevention of contamination
- Required clinical and performance evaluations
- Methods for collecting customer feedback
- Product realization has a more significant impact in 13485 and greater record requirements
What is ISO 13485 certification?
ISO 13485 certification is a voluntary process that requires an organization’s quality management system to pass a third-party Medical Device Single Audit Program (MDSAP) audit. Being officially certified for ISO 13485 demonstrates to customers and regulators that your medical device products reliably meet stringent quality standards.
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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