Medical Technology

According to the Medical Device Regulation (MDR), medical devices must be regularly checked for their usability. This must be proven with a usability file. Here we support a renowned manufacturer of products for ophthalmology in the evaluation of existing and new products. The goal is to create usability documentation that complies with national and international regulations.

Formative & summative Usability-Tests

In observation rooms, our partners from product management, regulatory affairs and quality management can follow the usability tests live. We moderate the tests, we summarize, we evaluate and we integrate the results into the documentation of our customers.

High quality standards

Recruiting the right user groups, building the right test setting, incorporating risk management, and formulating acceptance criteria: these are the quality features of our usability validations.

We validate the usability of the application of the medical device itself as well as accompanying materials, such as instructions for use and training materials.

Practical recommendations

The proper application of norms enhances product development and increases the user-friendliness of medical products. At Consulteer, we understand the importance of creating a seamless connection between regulatory requirements and usability. Our UX experts, product designers, and multidisciplinary teams work hand in hand to complete and continuously improve the user-friendliness of medical products as well as their accompanying documentation.