Michael Schubert

Statistical Interpretation and the Role of Meta-Analysis

This presentation provides a practical overview of how to plan, design, and conduct an in vitro diagnostic (IVD) clinical performance study under the EU In Vitro Diagnostic Regulation (IVDR). It covers key regulatory expectations, operational planning, and execution with monitoring and safety reporting. All which are of outmost importance to generate robust clinical evidence that supports IVD conformity assessment and market access.