Aero Pump develops pump systems for pharmaceutical, cosmetic and technical applications. Their products are registered as class 1 medical devices and therefore need to fulfill certain regulatory requirements.
We could help Aero Pump to meet the general safety and performance requirements of the European Medical Device Regulation and develop a product that is not only safe and easy to use, but well accepted by the intended patient groups.
Our task
In the early design phases, we assisted with gathering user feedback to improve the product and ensure safe use. We came on board to prepare and conduct the necessary usability study and also to help with documentation.
Challenges
The product should be designed in a way that it is well accepted by the targeted patient groups and also meets the general safety and performance requirements of the Medical Device Regulation.
Result
We successfully conducted the usability testing for Aero Pump. The study and report helped to prepare the documentation that is needed for the CE certificate and the market approval for the European market.
Further References
Let’s get started!
We would like to get to know you and your product. Together we can find out, what we can do for you and how we can support you in designing safe and easy to use medical devices with a great UX.