Making quality management more efficient
"During audits, we now carry only one laptop instead of multiple files and paper records."
Requirements management software for medical devices, made simple with Matrix Req
AI powered software to easily manage requirements, specifications, risks, test cases with complete traceability
For taking a demo with our team.
Trusted by life sciences leaders
4.3/570 reviews on G2
4.7/5on Capterra
5/5on Google
500+life sciences companies worldwideSpreadsheets and Word files were never built for design control.
Slide across to see what changes when everything lives in Matrix Req.
Requirements scattered everywhere
Engineering, quality and regulatory each keep their own documents. Change one requirement and you hunt by hand for every test and risk it touches.
Traceability that breaks
One missed link between a design input, a risk and its test can become a nonconformity at review time and push your launch back.
A risk file nobody trusts
Risk matrices live outside the development work, so they drift out of date and lose their link to the requirements that control them.
Weeks lost to audit prep
Every audit means rebuilding trace tables and chasing signatures across folders before the auditor arrives.
One repository for everything
Requirements, specs, risks and tests live in one versioned system. Change one item and Matrix Req shows every downstream impact.
Traceability that checks itself
Set which traces are required. Matrix Req flags broken, missing or outdated links before a reviewer finds them.
Risk linked to the work
ISO 14971 templates with your own scoring. Each risk links to the requirement that controls it and the test that proves it.
Audit ready on any day
Generate trace tables and design documents from live data, with a full audit trail and 21 CFR Part 11 signatures.
What you get, and when
Your first 90 days with Matrix Req
A typical rollout with one of our onboarding packages. Your pace depends on how much data you bring across.
Your team is working in it
Onboarding runs as two hour sessions with a Matrix Req specialist, planned around your team and the data you bring across.
Your Excel and Word data is in
Columns and sections map to Matrix fields, traces included. Some imports take one to two hours.
Your dev tools are linked
Create or link Jira, GitHub and GitLab issues from any item, set up during onboarding.
"The support has been second to none, with very fast responses and a comprehensive help function."
Verified review on G2, Sep 2026
Migration is done
With a full migration package, most teams are fully moved off their old tool in under two months.
Gaps show up on their own
Required traces are enforced, so missing tests and unlinked risks surface in dashboards, not at the design review.
Matrix Mind does the first draft
The built in AI assistant drafts requirements, risks and test cases in your own template.
"The biggest improvement Matrix Req has brought to our team is having one dependable source of truth for our development documentation."
Verified review on G2, Aug 2026
Documents in a few clicks
Your design history file and trace tables generate from live data, in the same Word format you used before.
Gaps checked against the standard
Compliance Checker turns a standard into a checklist and assesses your project item by item.
One laptop in the audit room
Records, signatures and change history come up on request, with the who, what, when and why of every edit.
"We can generate PDF documents in the same format as before in a highly automated way, improving our team's efficiency by an estimated 60%."
Matrix Req customer
Core features
Everything design control needs, in one place
Press play on a feature to watch it in action, built on one demo project: a wearable ECG patch, from first requirement to signed document.
2:36Design control and traceability
Create a requirement, its specification and its test case, all traced, then see the whole chain in one view.
Watch the 2:36 video
3:26Matrix Mind
The AI assistant inside Matrix Req drafts and refines requirements, specs and tests. Nothing lands until you approve it.
Watch the 3:26 video
1:35Jira, GitHub and GitLab
Create or link issues right from a specification, and issue keys you type turn into links.
Watch the Jira video
Risk management
Assess risks, link each control to the design item that implements it, and see residual risk.
Verification and validation
Plan, assign and run tests with a result for every step and live progress.
Technical documentation
Build a requirements specification from live project data and preview the PDF before it goes out.
Review and electronic signatures
Route a document for review, sign it under 21 CFR Part 11 and keep a full audit trail.
Compliance Checker
Turn a standard such as ISO 13485 or the MDR into a checklist and see in minutes where your documentation falls short.
What medical device teams say on G2
User friendly and highly customizable traceability
"It allows us to easily tailor custom fields and set up personalized traceability rules that fit our exact workflow."
Outstanding support and thoughtful AI
"Through our tender process, Matrix came out as the most cost effective between the 3 options submitted."
Consistent documentation from live project data
"The documentation stays connected to the requirements, risks, and verification work that's already being maintained in Matrix Req."
Audit ready traceability in one connected system
"Automated document generation eliminated much of the manual Word and Excel work."
Excellent medical device requirements management software
"We can see how a change affects downstream requirements, risk controls and verification activities without maintaining a separate spreadsheet."
Pricing
Billed yearly. Book a demo and we’ll walk you through every feature.
Team Plus
For a device team getting design control under control.
€10,860per year
- Includes 6 users
- Requirements, risks, tests and traceability
- Document generation and electronic signatures
Company Plus
Everything in Team Plus, plus a light QMS.
€15,420per year
- Includes 6 users
- Everything in Team Plus
- Light QMS: CAPA, document control, audits
Enterprise Plus
For larger organisations running several device programmes.
from€31,200per year
- Everything in Company Plus
- Includes 20 users
- Unlimited read and write users
- Free read only users
- Intranet hosting available
Questions we hear most
How long does implementation take?
Teams that already know an ALM tool are often productive within a few days. Onboarding runs as two hour sessions with a specialist, and with a full migration package most teams are live in under two months.
Can I import my requirements from Excel, Word or another tool?
Yes. Matrix Req maps your Excel columns or Word sections to its fields, so requirements, risks and tests come across with their traces intact. Our Premium package covers a full migration from another tool.
Is Matrix Req validated for FDA and ISO 13485 work?
We provide a validation package for Matrix Req itself: plans, reports, test scripts and traceability matrices. Teams use it for 510(k), PMA and CE mark submissions, with 21 CFR Part 11 signatures and audit trails.
Does it work with Jira, GitHub or GitLab?
Yes. You can create or link Jira, GitHub and GitLab issues straight from a requirement or specification, and issue keys you type in any text turn into links.
What AI features are inside Matrix Req?
Matrix Mind drafts requirements, risks and test cases in your template and helps you find anything in your documentation. Compliance Checker builds a checklist from any standard and assesses your project against it.
Is Matrix Req the same software as Matrix Requirements?
Yes. In 2025 the company rebranded to Matrix One and the software previously sold as Matrix Requirements became Matrix Req.
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.
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.
What happens if we outgrow our initial license size?
No problem! You can add users anytime. The upgrade is immediate, with no downtime or data migration required. Most of our clients grow 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.
How can I switch from my current set-up to Matrix Req ?
Over the years we have helped hundreds of medical device companies move away from paper based systems and legacy tools. Our customer success team has built data migration tools for whatever setup you have today, and our full migration package takes care of every step so that you can be up and running on Matrix Req in less than two months. Compare the onboarding and migration packages.
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.
See Matrix Req on a device like yours
A 30 minute demo with a specialist who knows medical devices.