Quality and compliance are paramount at Control-X Medical. We hold major medical certificates to comply with requirements on different markets. Our Quality Management System and our products are audited in accordance with EU rules by NEOEMKI and - from 26 September 2024 - by TÜV SÜD and are cleared by the FDA. In addition to our medical certifications, we are also certified under ISO 9001 and ISO 14001 norms by CERTOP.
Medical Device Directive 93/42/EEC Certificate*
ISO 13485 Certificate
Information on Devices Registered with the US FDA
ISO 9001:2015 and ISO 14001:2015 Certificate
* Please note that as from 26 May 2024 the Milestone X-ray Generator's certification has expired.