Requirements Management for Medical Devices Made Easy
Keep your design input and output under control to be ready for certification and audits when you need to be!
Document risks, requirements, specification, tests and test results in an modern and agile manner.
When in need of filing regulatory documents, we are simply ready to supply the external regulatory consultants with an orderly and highly accessible data set ... lowering our costs and getting things done faster.
Oron Zachar, co-founder/CTO Biovo Technologies, Israël
The tool is powerful and has proven to be an asset to our product development. I would highly recommend the product... I also commend the Matrix Medical team on the customer support.
Richard Smith, CEO Contex Canada
Matrix Requirements Medical provides a high degree of flexibility that allows fitting the exact needs of customers.... At Eff'Innov Technologies, we adopted this tool whenever the project complexity cannot be tackled using traditional hand-made documentation and traceability hooks.
Stéphane Visticot, Senior Architect, Eff'Innov Technologies, France
Ihr Matrix Requirements Produkt finde ich konkurrenzlos!
Regina Preysing, Requirements Engineering at Bodytel, Germany
Let me say again how much I like your product. I am the first in our company to go through a project with it and it has made life so much better. So, thank you!
Erik Herrmann, Senior Director of Spine Business, Orthosensor, US
I've looked at lots of requirements management tools and Matrix stands out for being streamlined and flexible
Aaron Joseph, Medical Devices Consultant, US
Personally I think yours is one of the best suppliers I've had the pleasure to work with yet... the responsiveness is just stellar!
Bernard Mensah, Principal Software Engineer at Balfour Beatty Services, UK
Nous sommes ravis de l'utilisation de la plateforme
Sébastien Lasserre, Scientist & Engineer at Mindmaze, Switzerland
Start early documenting your design input and output in an agile way. If you wait until the last minute you will have to reverse engineer your design and you will have to produce a huge pile of paper when the project is in its most critical phase. See how ...
Make a better product
Since you have real time visibility and traceability, everybody in the project can see not only what needs to be done but also why. Document the user and system requirements as required by regulatory standards. See how ...
Instead of one or two persons writing huge documents with a lot of technical details you can distribute work easily without loosing the big picture: engineers can write requirements and specification in their domain, quality assurance writes test cases, testers test, regulatory affairs can maintain the regulatory part. All traceable and documented. See how ...
Avoid project risks
58% of FDA submissions get delayed or fail because of bad technical documentation. Each risk which is identified too late will cause additional re‐engineering effort. Write, update and execute tests already while in development. Avoid loss of documentation due to server failures. See how ...
Know who is working on what. Know what changed. Know what needs to be changed. Know why it was changed. Know! See how ...
Understand your project
Since you can capture all design input and output in one place and because all the traceability is maintained automatically you know immediately what is still to do and what impact changes will have. See how ...