Quality management in accordance with DIN EN ISO 13485 and DIN EN ISO 9001 and Annex IV Section 3 of the Council Directive 98/79 EC on in vitro diagnostic medical devices (CE 0483; Annex II, list B).

• Product approval in accordance with MPG [German Medical Device Act] and Annex IV Section 3 of the Council Directive 98/79 EC on in vitro diagnostic medical devices (CE 0483 according to Annex II, list B).
   
• External testing laboratory in accordance with §14 and §64 AMG [German Drug Law] and GMP.
   
• Testing laboratory for veterinary vaccines (§13 Tierimpfstoffverordnung [Veterinary Vaccine Ordinance], §17a Tierseuchengesetz [Animal Infectious Disease Act]).
   
• Together with the company mdt, ZLG [Central Authority of the Laender for Health Protection Regarding Medicinal Products and Medical Devices]- accredited test laboratory in accordance with DIN EN ISO 17025, also GLP-compliant in the areas of virology, microbiology and cytotoxicology.
   
• BSL1 and BSL 2 safety levels in accordance with Infektionsschutzgesetz [Protection Against Infection Act] and Tierseuchen-VO [Animal Infectious Disease Ordinance].
   
• Licence for level S1 in accordance with Gentechnikgesetz [Gene Technology Act].
   
• Member of the "Virus Disinfection" specialist commission of the "Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e.V." [German Association for the Control of Virus Diseases] (DVV).