Lybe Scientific got its first product registered as a CE-marked IVD medical device fulfilling the requirements set by In Vitro Diagnostic Directive (IVDD). The company built an ISO 13485 compliant QMS in a short time with the help of Innokas’ QARA team and got registered as a legal manufacturer of in vitro diagnostic medical devices. This was a key milestone for further sales and marketing of Lybe Scientific’s products for diagnostic purposes.

“The efficient workflow and competencies of Innokas Medical were the most important reasons to choose the team. Based on the earlier good cooperation it was natural for us to continue working together”, says Tonje Steigedal who’s heading Lybe Scientific.

Lybe Scientific is a Norwegian start-up founded in 2021. The company focuses on the development of universal cost-effective sample preparation solutions that cover a wide range of nucleic acid-based diagnostic applications. The work is based on the patent-pending technology that originates from the research by the Norwegian University of Research and Science (NTNU) groups within clinical molecular medicine, nanotechnology, and chemical engineering.