Build devices, not documents
Matrix Req is requirements, risk and test management software for medical device engineering teams.
Pick a time on the next screen. 30 minutes, built around your device.
Thank you
A member of our team will be in contact within 48 hours.
Why engineering teams switch to Matrix Req
✕The old way
Requirements in Word, tickets in Jira, the trace matrix in Excel
- A 900 row trace matrix nobody trustsLinks are pasted by hand. Change one requirement and someone misses a test.
- Documents eat the sprintBefore each release, engineers stop building and put documents together by hand.
- Heavy ALM tools nobody opensBig tools take months to set up and cost a lot per seat. So engineers work around them.
✓With Matrix Req
One traceable system your engineers will use
- Traces that stay currentLink items once. Broken or missing traces are flagged for you.
- Documents from your dataTrace tables and design docs are generated, not built by hand.
- Productive within daysTeams used to ALM tools are productive within days.
What our customers say
“Matrix Review”
Most helpful: - The version control - The interconnection of projects within matrix - The easy signature process within the tool - The quick support by the Matrix team
“Lean application for technical documentation and maintenance of the QM system”
The best thing about Matrix is that it is kept simple without lacking features. Another very positive feature is the validation template that comes with it. This is an excellent basis for validating at least the essential functions. I am very enthusiastic about the traceability of individual requirements among each other. The support is also very positive. You receive feedback very quickly and are always ready to help.
“Flexible and Efficient to manage the Quality Management System, easy Documentation!!”
Moving From Paper-Based to Digital Document Management. User-friendly software. Easy and efficient to manage design and quality system. The introduction of Matrix Requirement software in the QMS System made it easy to retrieve & trace documents during External remote audits. Ease to present all QMS through the software virtually. The published view is streamlined, allowing anyone in the company to find the procedures and work instructions through the Live QMS viewer.
“Excellent medical device requirements management software”
Matrix Req gives us one place to manage user needs, design inputs, design outputs, risks and test evidence. The biggest improvement has been end to end requirements traceability. We can see how a change affects downstream requirements, risk controls and verification activities without maintaining a separate spreadsheet. For a regulated medical device team, that visibility is extremely valuable.
“A superb tool”
The advantages that Matrix gives to an organisation are priceless. To be able to use a tool to track inputs all the way from needs and requirements through to validation is incredibly useful. The customisability of the tool is also endless, and we currently have a great set up for what we need.
“Nice and easy traceability tool”
The ergonomic way to trace the different elements ( i am form the medical device industry).
“Intuitive, powerful, and fast: QMS tool with top traceability and service”
Very intuitive use (user interfaces, functions) Powerful capabilities to cover the entire scope of a QMS (e.g., ISO 13485) in one tool Traceability and auditability at the highest level Option for complete custom configuration via Admin Client Extremely fast service and response times Helpful AI agents tailored specifically to the tool's use case Fair costs
“Much Better Control Over Requirements and Testing”
Matrix Req has brought discipline into our requirements and testing management process. Instead of searching through several spreadsheets and documents to find relations between different elements of our projects, now we have a convenient way to view connections between requirements, tests and other artifacts. Impact analysis and reporting tools are especially useful since they simplify reviews and save us from administrative routine. In general, it has enhanced traceability and made internal reviews more uniform.
“One Source of Truth for Requirements”
The biggest improvement Matrix Req has brought to our team is having one dependable source of truth for our development documentation. We manage a large number of requirements and verification activities, and maintaining relationships between them manually was becoming increasingly difficult. With Matrix Req, we can link requirements to risks, tests, defects, and other development artifacts and review those relationships directly in the project. The change history and traceability capabilities are especially valuable during design reviews because we can quickly determine what was affected by a change. Another feature we use heavily is automated document generation. Instead of maintaining multiple versions of similar information in Word and Excel, we can generate reports using the current project data. This has saved our team considerable administrative effort.
“A Strong Foundation for Compliance Traceability”
Matrix Req has given our team a much more structured way to manage requirements, risks, testing, and design documentation. Before adopting it, we were constantly moving information between spreadsheets, Word files, and separate tracking tools, which made it difficult to know whether everything was still aligned. Having requirements, risk controls, verification activities, and defects connected in one environment has made the entire development process easier to manage. The traceability views are particularly useful during design reviews because we can quickly see which requirements are covered and where additional action may be needed. We also like the flexibility of the platform. The document generation capabilities have also reduced a significant amount of administrative work.
“Audit-Ready Traceability in One Connected System”
Matrix Req has significantly improved our medical device development process by providing end-to-end traceability across requirements, risks, testing, bugs, and design controls in one connected system. Its flexible configuration allowed us to fit the platform into our existing SOPs, while automated document generation eliminated much of the manual Word and Excel work. Reliable performance, strong customer support, intelligent impact analysis, and audit-ready reporting have reduced preparation time, minimized documentation errors, and delivered clear value for our regulated development environment.
“Great tool for small company.”
To be able to configure the workflow from scratch depending on the company's needs. The customer support is great. There is a bit of learning curve.
“The simplest and effective tool for traceability management Matrix Requirements”
For our Technical File, we use MatrixRequirements, a comprehensive platform that integrates the management of requirements, tests, test runs, risks and associated documentation in the medical device field. MatrixRequirements has been designed with great flexibility in mind, offering the possibility of configuring every aspect according to the specific needs of each company. By using MatrixRequirements, companies can effectively structure their practices, fostering optimal collaboration between R&D and quality teams. The tool guarantees simple, intuitive traceability, eliminating the burden of old methods that required hours of tedious work on endless spreadsheets. All in all, this translates into considerable time savings, reduced risk of non-compliance, and a clear improvement in documentation quality.
“Matrix ALM and QMS”
Matrix Requirements is an excellent off-the-shelf package for projects and managing documentation, requirements and planning within the ALM module. The off-the-shelf QMS package aligns with ISO 13485 and 820 allowing for flexibility in aligning the business to relevant requirements. The ease of use and administrative tasks are well managed and timely response to fix/assist with questions and issues is fantastic. Built-in Risk and CAPA modules are of good value and require minimal adjustment to suit business needs. The ability to link to Jira is a good function that allows agile work.
“Using Matrix for Years for test and requirement development.”
Very user friendly, easy to manage and use.
“Matrix Review”
Most helpful: - The version control - The interconnection of projects within matrix - The easy signature process within the tool - The quick support by the Matrix team
“Lean application for technical documentation and maintenance of the QM system”
The best thing about Matrix is that it is kept simple without lacking features. Another very positive feature is the validation template that comes with it. This is an excellent basis for validating at least the essential functions. I am very enthusiastic about the traceability of individual requirements among each other. The support is also very positive. You receive feedback very quickly and are always ready to help.
“Flexible and Efficient to manage the Quality Management System, easy Documentation!!”
Moving From Paper-Based to Digital Document Management. User-friendly software. Easy and efficient to manage design and quality system. The introduction of Matrix Requirement software in the QMS System made it easy to retrieve & trace documents during External remote audits. Ease to present all QMS through the software virtually. The published view is streamlined, allowing anyone in the company to find the procedures and work instructions through the Live QMS viewer.
“Excellent medical device requirements management software”
Matrix Req gives us one place to manage user needs, design inputs, design outputs, risks and test evidence. The biggest improvement has been end to end requirements traceability. We can see how a change affects downstream requirements, risk controls and verification activities without maintaining a separate spreadsheet. For a regulated medical device team, that visibility is extremely valuable.
“A superb tool”
The advantages that Matrix gives to an organisation are priceless. To be able to use a tool to track inputs all the way from needs and requirements through to validation is incredibly useful. The customisability of the tool is also endless, and we currently have a great set up for what we need.
“Nice and easy traceability tool”
The ergonomic way to trace the different elements ( i am form the medical device industry).
“Intuitive, powerful, and fast: QMS tool with top traceability and service”
Very intuitive use (user interfaces, functions) Powerful capabilities to cover the entire scope of a QMS (e.g., ISO 13485) in one tool Traceability and auditability at the highest level Option for complete custom configuration via Admin Client Extremely fast service and response times Helpful AI agents tailored specifically to the tool's use case Fair costs
“Much Better Control Over Requirements and Testing”
Matrix Req has brought discipline into our requirements and testing management process. Instead of searching through several spreadsheets and documents to find relations between different elements of our projects, now we have a convenient way to view connections between requirements, tests and other artifacts. Impact analysis and reporting tools are especially useful since they simplify reviews and save us from administrative routine. In general, it has enhanced traceability and made internal reviews more uniform.
“One Source of Truth for Requirements”
The biggest improvement Matrix Req has brought to our team is having one dependable source of truth for our development documentation. We manage a large number of requirements and verification activities, and maintaining relationships between them manually was becoming increasingly difficult. With Matrix Req, we can link requirements to risks, tests, defects, and other development artifacts and review those relationships directly in the project. The change history and traceability capabilities are especially valuable during design reviews because we can quickly determine what was affected by a change. Another feature we use heavily is automated document generation. Instead of maintaining multiple versions of similar information in Word and Excel, we can generate reports using the current project data. This has saved our team considerable administrative effort.
“A Strong Foundation for Compliance Traceability”
Matrix Req has given our team a much more structured way to manage requirements, risks, testing, and design documentation. Before adopting it, we were constantly moving information between spreadsheets, Word files, and separate tracking tools, which made it difficult to know whether everything was still aligned. Having requirements, risk controls, verification activities, and defects connected in one environment has made the entire development process easier to manage. The traceability views are particularly useful during design reviews because we can quickly see which requirements are covered and where additional action may be needed. We also like the flexibility of the platform. The document generation capabilities have also reduced a significant amount of administrative work.
“Audit-Ready Traceability in One Connected System”
Matrix Req has significantly improved our medical device development process by providing end-to-end traceability across requirements, risks, testing, bugs, and design controls in one connected system. Its flexible configuration allowed us to fit the platform into our existing SOPs, while automated document generation eliminated much of the manual Word and Excel work. Reliable performance, strong customer support, intelligent impact analysis, and audit-ready reporting have reduced preparation time, minimized documentation errors, and delivered clear value for our regulated development environment.
“Great tool for small company.”
To be able to configure the workflow from scratch depending on the company's needs. The customer support is great. There is a bit of learning curve.
“The simplest and effective tool for traceability management Matrix Requirements”
For our Technical File, we use MatrixRequirements, a comprehensive platform that integrates the management of requirements, tests, test runs, risks and associated documentation in the medical device field. MatrixRequirements has been designed with great flexibility in mind, offering the possibility of configuring every aspect according to the specific needs of each company. By using MatrixRequirements, companies can effectively structure their practices, fostering optimal collaboration between R&D and quality teams. The tool guarantees simple, intuitive traceability, eliminating the burden of old methods that required hours of tedious work on endless spreadsheets. All in all, this translates into considerable time savings, reduced risk of non-compliance, and a clear improvement in documentation quality.
“Matrix ALM and QMS”
Matrix Requirements is an excellent off-the-shelf package for projects and managing documentation, requirements and planning within the ALM module. The off-the-shelf QMS package aligns with ISO 13485 and 820 allowing for flexibility in aligning the business to relevant requirements. The ease of use and administrative tasks are well managed and timely response to fix/assist with questions and issues is fantastic. Built-in Risk and CAPA modules are of good value and require minimal adjustment to suit business needs. The ability to link to Jira is a good function that allows agile work.
“Using Matrix for Years for test and requirement development.”
Very user friendly, easy to manage and use.
“Matrix Review”
Most helpful: - The version control - The interconnection of projects within matrix - The easy signature process within the tool - The quick support by the Matrix team
“Lean application for technical documentation and maintenance of the QM system”
The best thing about Matrix is that it is kept simple without lacking features. Another very positive feature is the validation template that comes with it. This is an excellent basis for validating at least the essential functions. I am very enthusiastic about the traceability of individual requirements among each other. The support is also very positive. You receive feedback very quickly and are always ready to help.
“Flexible and Efficient to manage the Quality Management System, easy Documentation!!”
Moving From Paper-Based to Digital Document Management. User-friendly software. Easy and efficient to manage design and quality system. The introduction of Matrix Requirement software in the QMS System made it easy to retrieve & trace documents during External remote audits. Ease to present all QMS through the software virtually. The published view is streamlined, allowing anyone in the company to find the procedures and work instructions through the Live QMS viewer.
Questions engineers ask before a demo
Yes. The importer maps your Excel columns or Word sections to Matrix Req fields, so the links stay intact. Our team can also run the migration for you.
Yes. Create Jira tasks from requirements and link existing Jira issues. Developers stay in Jira, and the trace to requirements, risks and tests lives in Matrix Req. GitHub, GitLab, Azure DevOps and Confluence integrations are available too.
Yes. It covers IEC 62304 lifecycle evidence, ISO 14971 risk, and 21 CFR Part 11 signatures and audit trails. Teams use it for 510(k), PMA and CE Mark submissions. A validation package is available.
Teams used to ALM tools are productive within days. A full rollout with setup, data migration and training usually takes two to three months.
You pick a time on the next screen. It is a free 30 minute session with a solutions expert, built around your device and your toolchain. No slides, no obligation.
Retire the 900 row trace matrix
30 minutes with a solutions expert, built around your device. No slides.