Safe use does not happen by chance. It is the result of strong product decisions.
Andreas Ebermann | Senior UX Designer | Teamlead Austria
At Consulteer, usability engineering is not an isolated compliance step. It is part of our responsibility for products, systems, and digital solutions that must function safely and reliably in real medical practice.
For more than 20 years, we have supported manufacturers in regulated environments in bringing together use, design, and engineering - not driven by standards alone, but grounded in real-world application. This is how products emerge that meet regulatory requirements and remain sustainable throughout their entire lifecycle.
Usability Engineering
Ensuring usability with confidence.
Usability engineering describes the systematic process of ensuring the usability of medical devices. Its goal is to prevent use errors and the resulting risks, harm, or even death.
Key focus areas include:
users and patients
context of use and application
user interface and user interface design
requirements from standards, guidance documents, and medical device regulations
Usability engineering connects human factors engineering, risk management, and product development into a traceable and well-documented process.
Human Factors
Human-centered by design.
Human factors examine the interaction between user, device, software, and context of use. Usability engineering therefore does not start with the product — it starts with the people who will use it.
We analyze:
user groups and qualifications
use scenarios and critical use steps
workflows, environments, and time pressure
interfaces between device, software, instructions for use, and training
These insights form the foundation for use specifications, risk analyses, and design decisions.
Our Services
Usability Engineering for Medical Devices
Human Factors Engineering
User Research & Context Analysis
Use Scenarios & User Interface Specification
Formative & Summative Evaluation
Usability Engineering File
Trusted Partnerships.
Validate what matters in real-world use.
For more than 20 years, we have worked on complex products in regulated environments. We understand usability engineering as an integral part of product development - from the first usage concept through approval and beyond.
If you are looking for a partner who takes responsibility and ensures safe use across the entire product lifecycle, we look forward to connecting.
