Your mission is to improve Health. Ours is to make your Life easier.
Matrix One (previously Matrix Requirements) was launched as we saw a clear need for innovative Life Science companies struggling with the changing environment of regulation and the impact this was having on getting products to market.
In speaking to many Life Science companies, it was easy to see the difficulties Life Science companies were having with keeping up-to-date documentation or connecting their medical devices to the cloud.
After searching for solutions that were powerful enough to handle complex development nothing ticked all the boxes, so our co-founders built solutions to solve this problem, and from here Matrix Requirements was born.
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ISO 13485:2016, ISO/IEC 27001:2022, ISO 9001:2015 and HITRUST CSF
Lauxera Capital Partners, European health tech investor
2014, and bootstrapped for the first eight years
One platform, built and brought together
Matrix One began in 2014 as Matrix Requirements, founded in Germany by Yves Berquin and Wolfgang Huber, two computer scientists who had felt first hand how hard it was for medical device teams to keep documentation audit ready.
They bootstrapped the company and built the product that is now Matrix Req, our application lifecycle and quality management core.
In 2022 Lauxera Capital Partners backed the company, and from there the platform grew by bringing in the best teams in each part of the life sciences workflow.
In May 2025 Matrix Req and Galen Data came together under one name, Matrix One, so that every product a life science company needs to design, build and maintain a compliant medical device lives on a single platform.
Our original platform, built in house since 2014 for requirements, design control and quality management.
Joined us through the acquisition of Galen Data, a Houston company founded in 2016 that pioneered connecting medical devices to the cloud.
Came from Dokspot, a Zürich company specialising in electronic Instructions for Use.
Joined through the acquisition of Simploud, whose cloud quality management and laboratory information management software now sit inside the platform.
Every product independently audited
Compliance is not an afterthought here, it is the product. Each part of the platform has completed third party audits against the standards our customers are themselves audited against.
| Product | ISO 13485:2016 Medical device quality | ISO/IEC 27001:2022 Information security | ISO 9001:2015 Quality management | HITRUST CSF Healthcare security |
|---|---|---|---|---|
| Matrix Req | Certified | Certified | Not certified | Not certified |
| Matrix Connect | Certified | Not certified | Not certified | Certified |
| Matrix eIFU | Not certified | Not certified | Certified | Not certified |
| Matrix Quality | Not certified | Not certified | Certified | Not certified |
HITRUST CSF covers HIPAA, NIST and ISO requirements in one framework. Certificates for each are published on our Compliance and Certifications page.
What that is worth to the teams using it
Numbers our customers put their own name to, taken from published success stories rather than from our marketing.
50% increase in quality team productivity, 60% of the time saved on quality management processes, and 15 hours a month back from manual admin.
10x faster documentation creation and 3x acceleration of audit activities, on a Class IIa wearable.
From paper based processes and recurring FDA inspection challenges to 52 modules across 3 organisations since 2020.
Grew from 2 modules to 18 since 2019 while the team grew more than tenfold and the company absorbed acquisitions in the US and UK.
Overdue training cut by 50%, action delays down 25%, and 1,000+ controlled documents managed in one place after moving off paper.
A Zurich university spin off, self sufficient on the platform in 3 months, on a device that is Class III in the EU and Class II in the US.
“The time we saved was the most critical aspect of working with Matrix Connect. It would have been at least six months building cloud connectivity from scratch.”
“We recently had another PET drug approved by FDA, and Matrix Quality will help tremendously in the future with the rollout.”
“On top of them having the best solution in the industry, with Matrix Connect, for me, it’s the people. They have built trust with our team, I trust them, and that is invaluable for us.”
Every figure and quote on this page is drawn from a published Matrix One customer success story or from the customer directly. Read the full stories under Customer Success Stories.
Our office locations
Our teams are situated all over the world helping drive better patient care, everywhere. Five offices, five timezones, and a working day that runs eight hours wide from Houston to Tel Aviv.
- Entity
- Matrix Requirements GmbH
- Address
- Kehler Straße 22, 77694 Kehl
- Entity
- Dokspot GmbH
- Address
- Freudenbergstrasse 101, 8044 Zürich
- Entity
- Galen Data
- Address
- 1331 Gemini Street, Suite 305, Houston, TX 77058
When the whole company is in one place
Our first in person team meetup was in Lyon in 2019, when the team was five people. The last one was Athens in June 2026.
Our Timeline
From one product and one customer in Kehl, to five products and five offices.