Usability Testings for Medical Systems and Devices
The Regulatory Jungle
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.
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.
Covering the whole Process
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.
You are looking for a trusted partner to develop innovative digital health solutions or to mitigate risk of ongoing projects?
Together with you, we design standard-compliant medical products for the global healthcare market. Making products safe and intuitive to use are our two main focuses.
CEO Germany & Austria
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