Tool packages

Qarad created different packages which include useful tools and templates to help you overcome the challenges of the IVDR.

Hereunder, you can find more information about all our packages available at this time. Please note that not all packages are available yet. If you want to get updates when new packages are for sale, please contact us.

Compilation of an IVD STED file

• 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)

Writing Scientific Validity Reports

• 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

Clinical Evidence Requirements

• 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