Nikolaus Rajewsky

Prof. Nikolaus Rajewsky is a systems biologist at BIMSB Berlin who has contributed to the scientific regulatory frameworks for AI-based pathology diagnostics. He works at the intersection of advanced computational methods and regulatory science, examining how clinical validation studies should be designed for AI pathology systems seeking regulatory clearance. His perspective on European AI Medical Device Regulation (AIMD) helps bridge development and deployment requirements for digital pathology AI.