Quality management

The goal of our quality politics is the safety of patients and users, the fulfillment of our customers' requirements and the compliance with legal and official requirements.

The positive assessment of the quality of our products and services are essential for the success of our company.

Every day we improve and support the qualification, motivation and satisfaction of our employees.

The head office and the facility in the Biomedical Research Center (BMFZ) Rostock meet all the specific requirements of a medical device and medical biotechnology company.

We always ensure the effectiveness of our quality management system and the continued suitability of our quality politics, as a part of our continuous evaluation and improvement process.

We always place great importance on high quality and have been certified according to EN ISO 13485 by MEDCERT since 2013.

ISO 13485 is a worldwide standard especially for the medical device industry. The European standard EN ISO 13485 specifies the requirements for a quality management system (QMS) of a medical device manufacturer.

A successful certification demonstrates our corporate development and helps to continuously develop processes in the future. Thus we ensure the reliability and quality of all our processes.