• IVDR Performance Evaluation: An Executive Overview

    14 November 2023 IVDR
    Introduction In vitro diagnostic (IVD) devices are essential component of modern healthcare, for ...
  • EU IVDR Performance Validation Report: Steps and Requirements

    3 October 2023 IVDR
    European Union in Vitro Diagnostic Regulation (EU IVDR) 2017/746 is the European law concerning ...
  • eIFU for IVD: Country Specific Regulations and Benefits

    18 April 2023 IVDR
    There are several benefits of using electronic Instructions for Use (eIFU) labeling for medical ...
  • Trend reporting in IVDR context and Requirements

    11 May 2022 IVDR
       Introduction: Manufacturers of devices, made available on the Union market, ...
  • IVDR: Latest plan of action from MDCG

    19 April 2022 IVDR
      Set A – Essential ...
  • Is your Diagnostic State-of-Art? Are you sure & you think you can convince you NB?

    24 February 2022 IVDR
    You being "SURE", or your company thinks their Products have SOA does not help as it needs to be ...