Therapy device for pelvic floor muscle training
Field: Medical engineering
Task: Support in the medical device approval procedure
Customer: Acticore AG
The company Acticore has developed and launched a therapy device for the pelvic floor muscles. The therapy is based on the sensor-technical recording of muscle activity and, together with a mobile app, enables various therapeutic exercises. joylab supported Acticore during the approval procedure as a medical device. The device was tested for compliance with the medical standard IEC/EN 60601-1. In the course of this project we developed an insulation concept, and proved the device’s electrical safety according to the required measurements.
We were able to include the consideration from the perspective of the standard and the resulting findings in the development process. With the help of appropriate documentation, the approval procedure was simplified and the time to market significantly reduced.