Design Control made simple with Matrix Req software.

AI powered software to easily manage requirements, specifications, risks, test cases with complete traceability

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The challenge
Our solution
28%
Time saved
When writing, validating, and preparing technical documentation and audits.
91%
Customers feel more confident
During audits thanks to Matrix Req.
50%
Faster products launches
Customers brought their products to market sooner thanks to Matrix Req

Everything you need for high-quality medical device design

Design & Launch your medical device on the market faster with Matrix Req software, the all in one AI-powered Design Control & Requirements Management software made for Medical Devices companies.

Technical Documentation GenerationBuild your technical documentation in a few clics.
Risk ManagementDefine risks and risk mitigation according to customizable templates and formulas.
Test CasesDefine, plan, and execute multiple test cycles.
Design ControlStandard traces are defined. Configure traceability between items as optional or required. Identify broken, missing, or outdated traces.
Full Audit LogAll changes are automatically logged with user identity and timestamp. Compare revisions side by side to quickly see the changes and restore previous versions.
Integration with Other ToolsSynchronize documentation between Matrix Req and the other tools you work in like Confluence, TFS, and Jira.

Hear from our customers

With MatrixReq, we avoid all the challenges of using manual or custom-developed tools. Instead, we get a purpose-built solution that’s designed by medical device experts, enabling much faster ISO 13485 compliance.”

François Audéon, Chief Technology Officer

Matrix One is trusted by 500+ life sciences & medical device companies

FAQ

Can I import my existing requirements from Excel/Word/other tools?

Yes! Matrix has a flexible import system that maps your Excel columns or Word sections to Matrix fields. You can import requirements, risks, tests, and specifications with full traceability preservation. The process takes as little as 1-2 hours for some dataset! We also offer data migration services as part of our Full-Service Onboarding package.

How does change control and version management work?

Every change in Matrix is automatically tracked with a revision history (who, what, when, why). You can lock items when design freezes using labels, and create "signed" snapshots of documents for regulatory submissions. Matrix generates red-line comparisons between any two versions, eliminating manual Word document comparisons. Perfect for design control and 21 CFR Part 11 compliance.

Does Matrix integrate with Jira, Azure DevOps, or GitHub?

Yes! Matrix has native bi-directional integrations with Jira, Azure DevOps, GitHub, and GitLab. You can automatically create tickets from requirements, sync status updates, and maintain full traceability between requirements and implementation. Integration setup is included in our Comprehensive Onboarding package ($8,000).

Can we use Matrix for risk management (FMEA, ISO 14971)?

Absolutely. Matrix has a dedicated risk management module that supports multiple risk methodologies (FMEA, DFMEA, ISO 14971, hazard analysis). You can configure custom risk scoring matrices, link risks to requirements and mitigations, and generate compliant risk reports. We showed Medtronic how to handle complex multi-harm scenarios with automatic calculations.

How long does implementation take?

Typical implementation timeline is 2-3 months:

  • Week 1-2: Setup, configuration, SSO integration

  • Week 3-6: Data migration, custom template creation, admin training

  • Week 7-10: End-user training, pilot project

  • Week 11-12: Full rollout and go-live

For teams already familiar with ALM tools and depending on where you are in your design processes, it can be productive in a few days!

Is Matrix validated for FDA/ISO 13485 compliance?

Matrix is designed for regulated industries. We offer a Validation project that includes all the documentation (plans and reports), test scripts, and traceability matrices for your design projects. Many medical device companies use Matrix for 510(k), PMA, and CE Mark submissions. The platform supports 21 CFR Part 11 electronic signatures and audit trails.

What happens if we outgrow our initial license size?

No problem! You can add users anytime. The upgrade is immediate—no downtime or data migration required. Most of our clients grows with us, so we are ready to scale for enterprise deployment across your acquisitions.

How do you handle requirements that apply to multiple products (shared requirements library)?

This is what our Compose module does. You create a "Base Library" with shared requirements (electrical safety, biocompatibility, EMC, etc.), and individual products "Include" from that library. When you update a shared requirement, it automatically propagates to all products using it. Perfect for companies with multiple product lines or acquisitions.

Are there any AI features inside Matrix Req ?

Yes! In your day to day work, you will be assisted by Matrix Mind, a chat bot that can help you navigate across your documentation, our user manual and much more. Matrix Mind can also help you to create requirements, risks, test cases, based on your specific template. For audit preparation, you will be able to use our Compliance checker. The Compliance checker is able to create a checklist from any regulatory standards and make an assessment on your compliance for each item of the checklist.

How can I switch from my current set-up to Matrix Req ?

Over the years, we have helped hundreds of medical devices companies move away from paper based systems or legacy / non flexible system. Our customer success teams has built data migration tools that enable us to assist you in any set-up you may have. We offer a full data migration package in which we take care of every step so that you can be up and running on Matrix Req in less than 2 months.

Is my IP protected when using Matrix Req’s AI tools?

Our AI tools work in your own siloed environment. We have a Zero data retention agreement with our LLM provider. Your data is neither used to train our provider’s models or ours. Your data is safe and its confidentiality secured.