Dr. Sandra Neidhöfer is an expert in regulatory affairs in the IVD sector with a focus on technical documentation, performance evaluation in accordance with the IVDR and usability engineering. Prior to joining Metecon, she spent more than 16 years leading assay development projects in the fields of autoimmune diseases, haemostasis and infectious serology at an international diagnostics company. Her expertise is grounded in a doctorate in molecular biology from Johannes Gutenberg University Mainz.