Hidroxa SE30 Anti sweat device

Purpose and goal:

To design a new iontophoresis machine for the treatment of hyperhidrosis with improved ease of use for better adherence to treatment. To undergo electrical safety testing and compile the technical documentation required to apply for CE marking for the Antisvettmaskinen HidroxaSE30 to the Notified body. As well as creating a quality management system and starting to work according to that to prepare for certification according to ISO13485.

Expected results and effects:

The project was delayed when we had setbacks in the EMC testing, which took a long time to resolve. But once that was done the electrical safety testing went great and the creation of the technical documentation and our quality management system has worked well in consultation with the regulatory consulting firm that we have worked with.

Approach and implementation:

The project has consisted of weekly workshops with the regulatory consulting firm. We laid out the plan to build the technical documentation and the QMS. Between each workshop, we have produced text and worked on the development of the machine in parallel.

The texts have been reviewed by the consulting firm and difficulties discussed during the workshops. Through the consulting firm, experts in other subfields such as labeling, material knowledge and more have also been consulted. This arrangement has worked well and we in the company have gained knowledge about the regulatory aspects.