From the beginning our company has set a high value on quality. A high standard of quality assurance is an integral component of our mission statement and is permanently implemented into our daily work.
In 2002, our quality management system was certified according to DIN EN ISO 9001 and DIN EN ISO 13485. The certificates are regularly updated according to the newest versions of these standards.
Since 2003 all human medical device products are CE marked proving their compliance with the European In-Vitro Diagnostic Regulation.
Since 2007, we own an approval for our CMV, Rubella and Toxoplasma ELISA test kits (prenatal diagnosis) according to the European In-Vitro Diagnostic Regulation.
Moreover, we regularly participate in the national INSTAND survey with multiple human diagnostic test kits. The good results confirm the high quality and consistency of our participating test parameters.
|DIN EN ISO 9001:2015||DIN EN ISO 13485:2016||Approval: CMV, Rubella and Toxoplasma ELISA
Download as PDF document