Design Control made simple with Matrix Req software (formerly Matrix Requirements)
AI powered software to easily manage requirements, specifications, risks, test cases with complete traceability
Book a demoManaging Requirements, Risk & Traceability across the product lifecycle
Complete Traceability, Automated & AI powered Compliance & Much more.
Siloed Requirements and Fragmented Documentation
Engineering, quality, regulatory affairs, and risk teams often store requirements in disconnected tools (documents, spreadsheets, emails), making it hard to keep information consistent and up-to-date. When one requirement changes, you're manually hunting down every affected test, risk, and specification.
Unified Requirements Repository
Capture, manage, and organize all requirements, design artifacts, and test cases in one secure system. No more scattered documents — every item is versioned, searchable, and auditable.
Change one thing, and Matrix Req instantly shows you every downstream impact with warnings. No more missed connections during design reviews or audits.
Regulatory Complexity Across Jurisdictions
Medical devices must meet multiple global standards — FDA QSR 21 CFR 820, EU MDR, ISO 13485, ISO 14971 — each demanding rigorous documentation, traceability, and audit evidence. Making sure that your device meets every item of your check list requires a lot of manual work.
Built-In Compliance with Global Standards
Import your standard, create your own regulatory checklist and our AI Compliance checker will highlight all the gaps you may have and suggest modifications.
Traceability Breakdowns Across the Lifecycle
Maintaining end-to-end traceability between design inputs, risks, tests, and outcomes is mandatory. Any missed connections during design reviews or audits could lead to a non-conformity and a deferred time to market.
True End-to-End Traceability
Connect the Dots Automatically. Link requirements to design outputs, risks, and verification/validation tests. Live trace reports show exactly who did what, when, and why — so you’re always ready for audits.
Manual Risk Management and Poor Integration
Risk activities often live outside core development workflows, leading to manual updates, missed links between risks and requirements, and outdated risk matrices with limited visibility.
Integrated Risk Management
Plan, track, and mitigate risks with configurable ISO 14971-aligned templates. Risks link to requirements and tests, ensuring every safety concern is documented, measurable, and auditable. You can also use our AI regulatory assistant to identify new risks and suggest mitigations strategies.
Cumbersome Design Control and V&V Processes
Design control requires robust linking of requirements to design outputs and verification/validation (V&V) tests — but disconnected systems make test planning and audit trails inefficient and error-prone.
Simplified Design Control & V&V
Define multi-layered verification and validation cycles, automatically track results, and connect them back to requirements — reducing errors while strengthening design control documentation.
Time-Consuming Audit Preparation
Without automated traceability and centralized control, preparing for compliance audits or regulatory inspections is resource-intensive and stressful.
Ready-For-Audit Documentation
Generate professional documentation and trace tables directly from your data. With built-in audit trails and e-signature support, you accelerate inspections and certification submissions.
Collaboration Gaps Across Cross-Functional Teams
Lack of a unified platform leads to misalignment between R&D, QA, RA, and operations — extending review cycles, increasing rework, and slowing product releases.
Cross-Functional Collaboration
Break Down Silos. Boost Efficiency Matrix Req aligns engineering, quality, and regulatory teams on one platform. Automated workflows and shared dashboards keep everyone aligned — so decisions are faster and more informed.
Managing Requirements, Risk & Traceability across the product lifecycle
Siloed Requirements and Fragmented Documentation
Engineering, quality, regulatory affairs, and risk teams often store requirements in disconnected tools (documents, spreadsheets, emails), making it hard to keep information consistent and up-to-date. When one requirement changes, you're manually hunting down every affected test, risk, and specification.
Regulatory Complexity Across Jurisdictions
Medical devices must meet multiple global standards — FDA QSR 21 CFR 820, EU MDR, ISO 13485, ISO 14971 — each demanding rigorous documentation, traceability, and audit evidence. Making sure that your device meets every item of your check list requires a lot of manual work.
Traceability Breakdowns Across the Lifecycle
Maintaining end-to-end traceability between design inputs, risks, tests, and outcomes is mandatory. Any missed connections during design reviews or audits could lead to a non-conformity and a deferred time to market.
Manual Risk Management and Poor Integration
Risk activities often live outside core development workflows, leading to manual updates, missed links between risks and requirements, and outdated risk matrices with limited visibility.
Cumbersome Design Control and V&V Processes
Design control requires robust linking of requirements to design outputs and verification/validation (V&V) tests — but disconnected systems make test planning and audit trails inefficient and error-prone.
Time-Consuming Audit Preparation
Without automated traceability and centralized control, preparing for compliance audits or regulatory inspections is resource-intensive and stressful.
Collaboration Gaps Across Cross-Functional Teams
Lack of a unified platform leads to misalignment between R&D, QA, RA, and operations — extending review cycles, increasing rework, and slowing product releases.
Complete Traceability, Automated & AI powered Compliance & Much more.
Unified Requirements Repository
Capture, manage, and organize all requirements, design artifacts, and test cases in one secure system. No more scattered documents — every item is versioned, searchable, and auditable.
Change one thing, and Matrix Req instantly shows you every downstream impact with warnings. No more missed connections during design reviews or audits.
Built-In Compliance with Global Standards
Import your standard, create your own regulatory checklist and our AI Compliance checker will highlight all the gaps you may have and suggest modifications.
True End-to-End Traceability
Connect the Dots Automatically. Link requirements to design outputs, risks, and verification/validation tests. Live trace reports show exactly who did what, when, and why — so you’re always ready for audits.
Integrated Risk Management
Plan, track, and mitigate risks with configurable ISO 14971-aligned templates. Risks link to requirements and tests, ensuring every safety concern is documented, measurable, and auditable. You can also use our AI regulatory assistant to identify new risks and suggest mitigations strategies.
Simplified Design Control & V&V
Define multi-layered verification and validation cycles, automatically track results, and connect them back to requirements — reducing errors while strengthening design control documentation.
Ready-For-Audit Documentation
Generate professional documentation and trace tables directly from your data. With built-in audit trails and e-signature support, you accelerate inspections and certification submissions.
Cross-Functional Collaboration
Break Down Silos. Boost Efficiency Matrix Req aligns engineering, quality, and regulatory teams on one platform. Automated workflows and shared dashboards keep everyone aligned — so decisions are faster and more informed.
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.
Hear from our customers
With Matrix Req, 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
FAQ
Yes, after the acquisition of Galen data (now Matrix Connect), Simploud (now Matrix Quality) and dokspot (now Matrix eIFU), we decided to rebrand our brand name from Matrix Requirements to Matrix One. And Matrix Requirements software itself was rebranded to Matrix Req. However, our company still operates under the name Matrix Requirements Gmbh
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.