Quality System

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

 

Certification ISO 13485 SGS

icone_pdf Télécharger une copie des certificats ISO 13485