As a European medical device manufacturer, we are subject to Regulation (EU) 2017/745 on medical devices and EN ISO 13485. 

In addition, Speed Care Mineral meets the requirements for the quality management system of the conformity assessment procedures of the Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3) and the specific requirements of the regulatory authorities participating in the MDSAP program for medical devices, as well as the requirements of the Medical Device Quality Management System Regulations of the Taiwanese Technical Cooperation Program (TCP).

Speed Care Mineral is monitored by DNV Medcert Zertifizierungs- und Prüfgesellschaft für die Medizin GmbH as a notified body. We regularly provide the necessary evidence for our locations in the form of the following certificates: