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 

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