Quality Management Systems

Requirement, Risk & Test Management

for Medical Devices


Spend your time on your project, not on paperwork


Agile Requirement Management

Have your team maintain your device history file while it is being designed. Not before. Not after. MatrixALM will help you ensuring the correctness and support you creating the documents for certification.


Agile Quality Management System

Have processes and work instructions which are simple, efficient and easy to use and improve. Not SOPs written by someone else for someone else. MatrixQMS will help create a quality system which works for you, not against you.


Integrated Risk Management

Risk management needs to be integrated in the design process and the quality system. Not in some excels on some file server.


Verification and Validation

Plan and document your verification and validation activities while you design your device.

Yohann Ferreira

MatrixRequirements greatly helped us obtaining the 510k clearance.
The tool itself was mandatory in providing the traceability from our requirements to our tests as easily as using just few clicks. And the neverending and always friendly team support is alone a great plus

Design QA Engineer at Mindmaze, Switzerland

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

Katrien Van Parijs

Today we've had an audit by a big pharmaceutical group. I've shown them how we work with Matrix Requirements and they were really impressed (even by such simple things as the way you've implemented electronic signatures). So thanks a lot for this great tool you've created and the wonderful cooperation we get from you guys.

CTO, Belgium

Using Matrix
Requirements Medical

By using Matrix Requirements Medical you get the application lifecycle management solution for medical devices. If you need to adhere to standards like ISO 13485, FDA CFR part 11, FDA CFR part 820, IEC 82304, 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. MatrixQMS allows you to define a quality system according to ISO 13485:2016. It comes with predefined process templates and a gap analysis to get you started quickly and can be adopted to other standards, ….
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