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 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.
Give us a call.
We will adivise you personally.
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