EU IVDR Performance Evaluation in 8 Steps
The new revised EU Regulation 2017/746 is focusing specific guide...
IVDR Performance Evaluation: An Executive Overview
In vitro diagnostic (IVD) devices are essential component of mode...
EU IVDR Performance Validation Report: Steps and Requirements
European Union in Vitro Diagnostic Regulation (EU IVDR) 2017/746 ...
Literature Search standardization for CER/PER, PMS, and Vigilance
A systematic review of the literature, including both peer-review...