Quality management and

Our conscious step towards certification according to DIN EN ISO 13485 shows our commitment to the highest standards in medical technology. DIN EN ISO 13485 goes far beyond the requirements of other quality management systems such as DIN EN ISO 9001, particularly in the areas of product safety, production environment and risk management, and at the same time places great emphasis on quality control and continuous improvement. In addition, we meet the requirements for listing as a critical supplier in terms of both the European Medical Device Regulation (MDR, EU Regulation 2007/745) and the US FDA, which is required for medical technology approvals. We would be happy to offer you our know-how to support you in your approval processes.