Medical Device Design and Documentation Product | Matrix Requirements

Quality Management Systems,
Requirements, Risk & Test Management
for Medical Devices

TRY FOR FREE Schedule a demo
Switch language

Spend your time building Medical Devices, not on paperwork

We do nothing but helping Medical Devices manufacturers to succeed
We are ourselves ISO 13485 and ISO/IEC 27001 certified
No lock-in for your data.
No long term contracts.
Free support
We are helping 200+ companies around the world from startups to multinationals

Agile Requirements Management

Have your team maintain your design history file (DHF) while it is being designed, not before, not after. MatrixALM will help you to ensure the content is correct and support you in 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 Excel file on some server. With our applications, the risks are part of the traceability matrix.

Risk management integrated in traceability

Verification and Validation

Plan and document your verification and validation activities while you design your device, not once you think you are ready to release. MatrixALM provides the full traceability matrix from the requirements until the executed tests.

Verification and validation for your medical device

Connect Matrix with your favorite tools

Github Gitlab Broadcom Rally Phabricator Slack Jira YouTrack
... and many more, contact us to see how we can help you to streamline your production

Interested to see more?

satisfaction score
satisfaction score
4.9 / 5
This is your average support rate you gave to us via JIRA Service Desk.
We are always here to help you!

The Matrix Requirements Support team
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
Thomas Gustafsson
I am working as a consultant helping clients master systems engineering tasks and especially requirements engineering with a focus on developing high quality requirement expressions and establishing end-to-end traceability using the V-model. This was my first experience of Matrix ALM and I just want to tell you how impressed I am. It is the first ALM solution I have tried that is truly usable out-of-the-box without customizations which I find being a key driving requirement for small and medium enterprises regardless of business area.

Senior consultant System Engineer at Etteplan
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 at 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 at Contex, Canada
Stéphane Visticot
MatrixALM 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 at 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
Lily Martyn
We've just had a 13485 stage 2 audit and the auditor said in the closing meeting "One of the best QMS applications I've seen"

Quality Manager at Genomics PLC
Scott Xiao
Matrix was one of the key tools we used in the development of Luminopia One, and allowed us to generate design history file documentation with ease and confidence. Many of the outputs from Matrix were submitted as part of our FDA De Novo application, and provided a foundation for the first FDA-approval of a virtual reality based digital therapeutic.

Co-founder and CEO at Luminopia
Umesh Sharma
It has been more than one year since we have using Matrix QMS software. Pleased to inform you that we have completely transited paper based QMS into digital. Last year we faced many regulatory audits, all online and onsite audits went smooth with Matrix and auditors were quite convenient with Matrix. I found document traceability is very easy and software is very flexible to accommodate all kinds of QMS and regulatory requirements.

Head QA/RA, Meril Life Sciences India Pvt Ltd
Robert Vogtherr
I have to mention how great Matrix works for us - so far, all employees, all external stakeholders and also our auditors were always impressed by the unique traceability and the extremely efficient possibilities of document creation.

Quality Engineer, B. Braun Group

Using Matrix Requirements for Medical Device Development

By using MatrixALM you get the ALM (application lifecycle management) solution for medical devices. If you need to adhere to standards and regulations 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, ….
© 2021 All rights are reserved, v Manage cookies on this site Legal / Impressum