Upcoming sessions

  • June 11, 2019: A practical approach for writing Scientific Validity Reports
  • Sept. 3, 2019: Compilation of your IVD STED file
  • Sept. 17, 2019: How to set up your Post-Market Surveillance?

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Qarad Academy!

A practical approach for writing Scientific Validity Reports

In the Scientific Validity Session we will address the legislative requirements in terms of scientific validity as required per the IVDR Article 56 and Annex XIII.

Tools

  • Intended Use
    How to build the intended use statement to address all relevant elements required per the legislation
  • Literature Review protocol
    Defining of search terms and literature review criteria
  • Literature Selection Table
  • Literature Review Report
  • Scientific Validity Report - Report build up + focus points

Trainers: Kirsten Van Garsse and Sara Van Wouwe

How to compile the STED file for your IVD products?

Our senior consultants will introduce you to the IVDR via a very practical workshop regarding the compilation of your STED file.

You will get access to the following tools: 

  • Intended Use template: How to formulate a clear intended use for your products?
  • General Safety and Performance Requirements
    • Comparison GSPR – ERC: What are the differences between the requirements in the IVDD vs. the IVDR
    • GSPR Checklist
  • STED Templates
    • General STED (IVDR Annex II)
    • STED for Post-Market Surveillance (IVDR Annex III)

The Clinical Evidence Requirements

In the Clinical Evidence session we will address the legislative requirements in terms of clinical evidence as required per the IVDR (Chapter VI, Annex XIII and Annex XIV).  Performance evaluations must be planned, conducted and documented in accordance with Article 56 and Annex XIII. In this practical session we will also introduce the concept of a Performance Evaluation File.

Tools

  • The Performance Evaluation Plan - What type of information is required
  • The Analytical Performance Report - What type of information to use and how to use the template
  • The Clinical Performance Report addressing all possible elements:
    • Literature Review
    • Published Experience gained
    • Clinical Performance Studies
  • The Performance Evaluation Report

A workshop on Clinical and Analytical Performance Studies according to the IVD-R

The training will be focussed on Analytical and Clinical Performance Studies:

  • Explain different performance characteristics required by the IVD-R
  • Applicability of these performance characteristics for different types of IVD products
  • Practical approach to determine the Analytical and Clinical Performance Characteristics with performance studies

Tools

  • Combined Analytical Performance Study Protocol/Report
  • Clinical Performance Study Plan
  • Clinical Performance Study Report

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