At Axilum Robotics, we are committed to ensuring the compliance of our robotic medical devices to the regulatory requirements in the European Union and the United States. We design, develop, manufacture, sell and provide after-sales support to our worldwide customers and make our best to satisfy their needs and requirements while keeping a high level of safety, performance and reliability to our medical devices. Our daily actions all converge into the maintenance of the effectiveness and efficacy of the company’s quality management system and high satisfaction of our customers.
The Quality Management System of Axilum Robotics has been certified to match the requirements of ISO 13485 standard by SGS. 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).