A product passes the audit. A system proves itself in everyday use.
Andreas Ebermann | Senior UX Designer | Teamlead Austria
Medical devices are not created in isolation — not only in CAD models or software backlogs. They emerge through the interaction of humans, technology, and context: in clinical routines, laboratories, production environments, or service use.
For more than 20 years, Consulteer has been a trusted partner in the development of medical systems. We combine human-centered design, engineering excellence, and regulatory requirements into solutions that are safe to use, fully traceable, and robust in both audits and real-world practice.
Our clients include companies in MedTech, medical technology, diagnostics, and digital health - among them well-known organizations such as Carl Zeiss Meditec, Hettich, Vitagroup, and Hexagon.
Designed for Humans.
Understanding the context of use.
Every medical project begins with real-world usage: Who works with the device? In what environment? Under what pressure? With which risks?
We analyze workflows on site, model usage concepts, and translate human factors insights directly into design and engineering decisions. At Consulteer, human factors and usability engineering guide development from the very start - they are not a downstream verification step.
Result: systems that are safe to operate, reduce use errors, and are accepted by their users.
Our Approach.
Think systemically. Execute precisely.
Consulteer develops medical devices within the context of their overall system. Depending on the project, we support individual components or take responsibility for the complete system - always with a clear focus on use, risk, and regulatory approval.
A medical system typically includes:
the medical device itself (mechanics, electronics)
software and interfaces (embedded systems, apps, platforms)
usage concepts and workflows
human factors & usability engineering
risk management and validation
documentation and audit-ready traceability
Medical Device Design & Product Design
Engineering & System Architecture
UX/UI for Medical Devices & Software
Prototyping & Implementation
Documentation & Compliance Support
Between Audits & everyday Life.
Implementing regulatory requirements with confidence.
In medical technology, every design and engineering decision is safety-critical. Requirements from MDR, FDA, ISO 13485, ISO 14971, and IEC 62366 shape the entire development process - from early concept through long after market launch.
Typical challenges we address include:
complex use scenarios in clinical and industrial environments
diverse user groups with varying levels of experience
increasing software and connectivity demands
high documentation and validation effort
time and resource pressure in product development
What sets us apart.
20 Years of MedTech Experience.
For more than 15 years, we have developed products for companies such as Zeiss, OCULUS, and Fette Compacting - from concept through regulatory approval.
One-Stop Partner.
We integrate human-centered design, software development, and regulatory affairs into one seamless product development process.
Validated Usability.
We test in clinical scenarios with real user groups - ensuring safe, usable products in accordance with IEC 62366-1.
From concept to system. Built to be compliant.
For more than 20 years, we have partnered on complex products and solutions in regulated industries — from mechanical engineering and MedTech to defense and security. Our projects are rarely short-term, often multifaceted, and always designed for long-term success.
If you are looking for a partner who understands regulatory frameworks, takes responsibility, and supports products throughout their entire lifecycle, we look forward to connecting.
