The Impact of the IVDR on IVD Clinical Performance Studies
With the full implementation of the In Vitro Diagnostic Regulation (IVDR) in the European Union, the landscape for clinical performance studies involving in vitro diagnostic (IVD) devices has undergone significant […]
Navigating Companion Diagnostics (CDx): Development and Regulatory Pathways
The rapid evolution of personalized medicine underscores the growing importance of companion diagnostics (CDx), making it a pivotal area of focus for regulatory affairs executives in the IVD industry. Here, […]
Optimizing Your Performance Evaluation Report (PER) for IVDR
The European Union’s In Vitro Diagnostic Regulation (IVDR) presents a rigorous regulatory framework that demands high standards of clinical evidence, making the Performance Evaluation Report (PER) a critical document for […]
