General Safety and Performance Requirements (GSPR)
What is GSPR?        The GSPR is known as General Safety and Perf...
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...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, Apr 2023
USA (FDA) | CANADA (HEALTH CANADA) | EUROPE | SWITZERLAND (SWISS M...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, Nov 2022
EUROPE (EU) | UK (MHRA) | IRELAND (HPRA) | CANADA (HC) |Â USA (FDA)...
