Quality System

The Quality Management System of Axilum Robotics has been certified to match the requirements of ISO 13485 standard by the Notified Body SGS 0120. This certification confirms that the company fulfills the requirements applicable in Europe to organizations manufacturing and commercializing medical devices. Therefore, Axilum Robotics applies the high level quality requirements of ISO 13485 and the EU Medical Device Directive in the development, manufacturing, sales and servicing of its assistance robots for transcranial magnetic stimulation (TMS).

 

Certification ISO 13485 SGSicone_pdf Download a copy of the ISO 13485 certificate