Data Extraction and Appraisal Tables in Systematic Literature Reviews: What a Notified Body Expects to See
Author: Sarah VanVickle Chaves, Director of IVD and Scientific Writing Services, Ph.D. Molecular and Cellular Biology For medical device and in vitro diagnostic (IVD) manufacturers, identifying relevant literature is only […]
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, […]
