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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!

The free edition gives you all features for one user with a limited amount of data

Document risks, requirements, specification, tests and test results in an modern and agile manner.

Gain time

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 ...

Distribute work

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 ...

Get Control

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 ...

Using Matrix Requirements Medical you get the requirement management lifecycle solution for medical devices. It allows you to capture all types of requirements and to develop test cases directly from it. The traceability matrices allow you to see and fix traceability issues quickly. After entering and analyzing your requirements, risks, test cases for verification and uses cases for validation you can use all this information to create your DHF documents which you will need for example for FDA or CE submissions and audits.
Matrix Requirements Matrix Requirements Medical Matrix Requirements Medical logo Requirements, Risks, Tests and Document Control For Medical Devices Made Easy