DIN EN ISO 13485
We have committed ourselves to develop products in accordance with DIN EN ISO 13485. This means our quality management system meets all necessary regulatory requirements to design and produce medical devices, including an accompanying risk analysis through every step of the development and post-market-surveillance process.
EU IVD Directive 98/79/EC-Medical Device Software
Momo, our microbiological analytics and clinical tool for reporting pathogens and antimicrobial resistances, received a declaration of conformity for the EU IVD Directive 98/79/EC. It is now a declared medical device and CE (Conformité Européenne) marked, indicating that it complies with all EU standards for health and safety.