Usability Engineering

Do you want to provide your users with the best possible user experience with your hardware and software to ensure the greatest level of user satisfaction and minimal user risk? Or do you want to meet usability requirements of notified bodies? If you are looking for support from a highly skilled team of usability experts, contact us today.
Helbling has got the answer!

We help you with the following core services

User Centered Design

We support you throughout the entire development process for medical devices or commercial products so that you do not lose sight of the user. In regularly addressing user-related issues, we promote greater end-user acceptance in the use of your product and reduce the risk of critical application errors. More details

Usability Testing, Formative und Summative

We perform usability testing for all project phases, with initial paper prototypes through to final design. Your project will be overseen by our experienced usability experts. More details

ISO 62366-1 and FDA compliant Usability Process

We have an EN ISO 13485:2016-certified MedTech development process and observe ISO 62366-1 and current FDA Human Factors Guidance in our usability engineering. Our experienced usability experts help you prepare the usability engineering file or human factors summary report (FDA). More details

User Centered Design based on ISO 62366-1 and FDA Requirements

We put users at the center by identifying needs and developing application scenarios. Based on this, we define design concepts and create prototypes. In the next step, we evaluate these with experts or end users, paying particular attention to ease-of-use and risk minimization. The output supports concept optimization up to the final product design. We consider ISO 62366-1 and FDA requirements especially in the case of medical devices and combination products.

Usability Testing, Formative and Summative

To clarify usability issues, we conduct formative or summative usability tests for you in Europe and the USA. These can take place in-house or in external facilities.

We are your partner for

selecting the appropriate test method (simulated use test, interviews, expert reviews, etc.)
supporting participant recruitment with external partners
preparing the required documentation
conducting the actual tests
providing a detailed analysis of the test results
developing design improvements

In the case of medical device testing, prototypes are customized to ensure ergonomics and participant safety.

The product being tested is examined and documented based on a usability protocol.

ISO 62366-1 and FDA compliant Usability Process

Medical devices to be approved in the EU or the USA need to meet certain local authority requirements. With our usability process we support you in creating all necessary usability documents based on the requirements of these authorities.