Company / Quality Assurance

Quality Assurance

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 OGYEI EMKI 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

FDA Compliance Certificate


ISO 9001:2015 and ISO 14001:2015 Certificate