VIRO-IMMUN's quality management system is certified according to DIN EN ISO 13485:2012 and DIN EN ISO 9001:2008. The scope
of the certificate covers design and production of in vitro diagnostics. The quality management of VIRO-IMMUN ensures that the products conform with the directive's requirements.
Continuous improvement processes serve to further raise the already high standard levels of the product quality. These
efforts also include customer interaction and service processes in order to continuously exeed our customer's expectations. The quality management system has been successfully implemented in every
business unit and been reaudited and validated in September 2015 by TÜV SÜD Product Service GmbH.
The CE-sign on our products certifies that VIRO-IMMUN complies with all requirements of the IVD directive on safety and
efficacy. VIRO-IMMUN is also entitled for the products Chlamydia, Cytomegalo virus, Rubella and Toxoplasma which are regulated by IVD-directive appendix II / list B by Gruppe TÜV SÜD Product Service
GmbH .These products have a CE mark and bear the additional identification no. "0123". All other products are audited regulary and as a visible sign for production complying to the IVD-directive the
products are also labeled with a CE-mark without the addition "0123".
All Declarations of Conformity ( in vitro diagnostics reagents and test kits and appendix II / list B
products ) and Material Safety Data Sheets are available upon request.