In Vitro Diagnostic Regulation (IVDR) – General Aspects, Key features and Limitations
Introduction to IVDR:
The In Vitro Diagnostic Regulation (IVDR) re...
EU IVDR Performance Evaluation in 8 Steps
The new revised EU Regulation 2017/746 is focusing specific guidel...
Using Benchmarks to Show Compliance EU MDR and EU IVDR
Benchmarking is a formal procedure of evaluation in a process or s...
IVDR Performance Evaluation: An Executive Overview
Introduction
In vitro diagnostic (IVD) devices are essential compo...
EU IVDR Performance Validation Report: Steps and Requirements
European Union in Vitro Diagnostic Regulation (EU IVDR) 2017/746 i...
eIFU for IVD: Country specific regulations and Benefits
There are several benefits of using electronic Instructions for Us...
