Quality management and regulation

We are your specialist when it comes to regulatory requirements for manufacturers and suppliers of subcomponents or pre-packaged medical devices.

DIN EN ISO 13485

Our deliberate move towards certification in accordance with DIN EN ISO 13485 demonstrates our commitment to the highest standards in medical technology. DIN EN ISO 13485 goes far beyond the requirements of other quality management systems as e.g. DIN EN 9001, particularly in the areas of product safety, production environment and risk management, while at the same time emphasising quality control and continuous improvement. We also fulfil 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 are happy to offer you our expertise to support you in your approval processes.

Quality, reliability and compliance

If you are looking for quality, reliability and compliance in medical technology, we are your partner of choice. Trust our expertise and commitment to fulfil your requirements. Contact us today to find out more!