Dunja Schildge-Reichmann is a project lead specialising in IVD regulatory submissions and the management of complex customer projects in the medical device and diagnostics sector. She brings extensive experience in the development and validation of assays and software products for immunodiagnostics, as well as in the preparation of technical documentation in accordance with the MDR and IVDR. Her expertise is grounded in a degree in biology and several decades of industry experience in development, regulatory affairs and quality management.