IVDR tools and templates

Since the possibilities for on-site trainings or classroom sessions have been limited due to the recent COVID-19 outbreak, Qarad has created a brand new solution to share its experience with others: the Qarad Academy IVDR tool and template packages.

We’ve selected the most intriguing topics of the IVDR and a specific package was created for each topic. These packages consist of tools and templates developed by our regulatory experts to help you create documents in line with the IVDR, in order to comply to its high standards. 

If you need assistance using our templates, you can opt to buy our promotion pack which includes 2 hours of consulting.

Compilation of an IVD STED file

  • Intended Use template
    How to formulate a clear intended use for your products?
  • Summary of Technical Documentation templates
    • General STED template
    • IVDR Annex II
    • STED for Post-Market Surveillance
      (IVDR Annex III)
  • General Safety and Performance Requirements
    • GSPR checklist
    • Comparison GSPR – ERC:
      what are the differences between the requirements in the IVDD vs. the IVDR?
    • List of harmonized standards under the IVDD

The Clinical Evidence Requirements

  • Intended Use template 
    How to formulate a clear intended use for your products?
  • Performance Evaluation Plan template
  • Performance Characteristics and list of CLSI documents 
  • Analytical Performance Report template
  • Clinical Performance Report template addressing all possible elements:
    • Literature Review
    • Published Experience gained
    • Clinical Performance Studies
  • Performance Evaluation Report template 

Writing Scientific Validity Reports according to the IVD-R

  • Scientific Validity Report objective template 
  • Scientific Validity Report template 
  • Literature search and selection protocol template 
  • Literature selection tables template 
  • Literature search and selection report template  

Analytical and Clinical Performance Studies according to the IVD-R

  • Analytical Performance Study Plan template 
  • Clinical Performance Study Plan template 
  • Clinical Performance Study Report template 

How to set up your Post-Market Surveillance (PMS)?

  • Post-market Surveillance Plan template 
  • Post-market Surveillance Report template 
  • Periodic Safety Update Report template 
  • Post-market Performance Follow-up Plan template 
  • Post-market Performance Follow-up Evaluation Report template 
  • Summary of Safety and Performance template

Setting up your Risk Management System

  • Risk Management Plan template 
  • Risk Management Report template 
  • Risk Analysis FMEA Tables template (incl. examples) 
  • Risk Assessment Record template 
  • Roadmap to Risk Assessment

How to approach distributors and importers?

  • List of Economic operator obligations 
  • Template of QA/RA Agreement with distributors 

Please fill in the form below to request more information or prices for the available tool packages.