Qarad Academy training sessions

Setting up your Risk Management System

During this practical course, Dr. Dirk Stynen will teach you how to do an actual risk analysis on your products.

We will start with some presentations on the following topics:

  • Risk analysis and risk management
  • The harmonized standard ISO14971:2019
  • Introduction to Qarad's roadmap to risk analysis for IVD 

Afterwards, we will proceed with practical exercises on:

  • Determination of product characteristics related to safety
  • Determination of the primary hazard associated with a product
  • FMEA of a product 

How to set up your Post-Market Surveillance?

In the “How to set up your Post-Market Surveillance” session we will address the legislative requirements in terms of Post-Market Surveillance (PMS) as required per the IVDR (Chapter VII).

Post Market Surveillance must be planned, conducted and documented in the technical documentation on Post Market Surveillance (Annex III). In this practical session we will discuss the PMS Plan and PMS Report or Periodic Safety Update Report (PSUR). We will also review the vigilance requirements and the new Manufacturer Incident Report.

Tools:

  • STED for Post-Market Surveillance (IVDR Annex III)


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.

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 Performance Studies according to the IVD-R

The training will be focussed on 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 Clinical Performance Characteristics with performance studies

Tools

  • Clinical Performance Study Plan
  • Clinical Performance Study Report

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