MDR CE mark for SilverFit systems

As of May 24th of this year, European regulations for medical devices are changing.
SilverFit is proud to announce that since this month, its medical products already meet these new MDR requirements for the CE mark. Our way of working is also certified and meets the ISO 13485 standards for medical products and the IEC 62304 standards for medical software.

This means, for example that:

- all exercises are tested against guidelines and scientific insights;
- we identify and address risks per exercise;
- we keep track of any changes to the systems;
- we regularly gather input from you, our users, on how we can improve further.

All our systems are also registered in the European medical device database EUDAMED.

Our systems comply with standard regulations. For each SilverFit system, we have listed all the important information:

- SilverFit Mile

- SilverFit 3D

- SilverFit Newton

- SilverFit Flow

- SilverFit Rephagia

- SilverFit Alois is not a medical device and therefore has no certification.