Requirements Management for Medical Devices Made Easy

We believe you should spend your time building medical devices, not their documentation

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.

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

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.

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.

Get Control

Know who is working on what. Know what changed. Know what needs to be changed. Know why it was changed. Know!

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.

More reasons

The V-Model is outdated

While it explains nicely what needs to be done and how it should be documented, it is not how modern teams work: in an agile world where requirements and regulations constantly change and where time to market is more critical than ever, there is just no time to work accordingly.

Document-based requirement engineering is outdated

For the above reasons it does not make sense to have one or very few people updating big documents like structures during the project. Requirement engineering in modern environments is a collaborative effort. Team members need to know immediately if something changed, why it changed and fix issues while they are working on the design itself.

Document-based technical files are outdated

While they are required for a submission they are extremely hard to maintain if the project runs in an agile way or under challenging deadlines. There are too many links and dependencies between the documents which makes it hard to ensure they are correct. There are too many stakeholders in the project to be sure the right updates are done in the right documents.

Thijs van Oorschot

Upon suggestion the feature was immediately implemented in test/acceptance environment saving us a lot of time (and irritation) on the process of copy-pasting information.

Founder & Technical Director at NightBalance, Netherlands

Sébastien Lasserre

Nous sommes ravis de l'utilisation de la plateforme

Scientist & Engineer at Mindmaze, Switzerland

John Beasley

Yes, the 510(k) was a success. I was very fortunate that the guys had the information so well organized. I believe it was your tool that helped tremendously in that success.

Senior Consultant at MedTech Review, USA

Oron Zachar

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.

co-founder/CTO Biovo Technologies, Israel

Richard Smith,

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.

CEO Contex Canada

Stéphane Visticot

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.

Senior Architect, Eff'Innov Technologies, France

Regina Preysing

Ihr Matrix Requirements Produkt finde ich konkurrenzlos!

Requirements Engineering at Bodytel, Germany

Erik Herrmann

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!

Senior Director of Spine Business, Orthosensor, US

Aaron Joseph

I've looked at lots of requirements management tools and Matrix stands out for being streamlined and flexible

Medical Devices Consultant, US

Bernard Mensah

Personally I think yours is one of the best suppliers I've had the pleasure to work with yet... the responsiveness is just stellar!

Principal Software Engineer at Balfour Beatty Services, UK

Using Matrix
Requirements Medical

By using Matrix Requirements Medical you get the requirement management lifecycle solution for medical devices. If you need to adhere to standards like ISO 13485, FDA CFR part 11, FDA CFR part 820, IEC 62304, IEC 62366 and ISO 14971- this is the tool to help you minimize the administrative overhead. It allows you to capture all types of requirements and to develop test cases directly from them. The traceability matrices allow you to see and fix traceability issues quickly. After entering and analyzing your requirements, risks, test cases for verification and use cases for validation you can use all this information to create the documentation needed for FDA or CE submissions and audits.
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