Design Control made simple with Matrix Req software.
AI powered software to easily manage requirements, specifications, risks, test cases with complete traceability
Book a demoEverything 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.
Hear from our customers
FAQ
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.
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.
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).
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.
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!
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.
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.
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.
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.
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.
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.