logo

QA/RA Consulting, Auditing & Training

logo

Let's get started

Jul 03, 2023

Understanding EU IVD Performance Evaluation Plan and Report Requirements in the IVDR

IVDR

May 15, 2023

Why Most Self-Certified IVDs Must Comply with the EU IVDR Right Now

Apr 03, 2022

Understanding EU IVD Performance Evaluation Plan and Report Requirements in the IVDR

EU MDR (2017/745) Update

Apr 01, 2021

Latest EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) Updates

Apr 06, 2020

Get Your Medical Device or PPE on the EU Market to Help with COVID-19. Here’s How