Stationary Neurofeedback Device
In neurofeedback, the electrical activity of the brain is measured in real time via EEG and fed back to the user as an image or sound. Through targeted training, the brain's self-regulation can be improved.
Setup
This neurofeedback product family comprises two devices: a mobile one for home use and a stationary one used at the therapist's practice. The device was planned as a Class IIa medical device under the MDR.
Assignment
All mechanical components were developed over several iterations, from the first prototype to the series product. Electronics and software came from specialists; the electronics platform and industrial design are coordinated with the mobile sister device, so that both devices use the same base.
Design work was carried out throughout in accordance with the requirements of the Medical Device Regulation. This concerns the choice of materials for anything that touches skin, the breaking loads of load-bearing parts, and the mechanical patient separation — the barriers that protect the patient even if the electronics fail.
Result
The device was certified and approved as a medical device and deployed at the customer's site. The project also gave rise to a small batch of silicone and 3D-printed parts.
Numbers & Facts
- ▪certified and approved as a medical device
- ▪shared electronics platform with the mobile sister device
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