Technical Documentation

Qarad can assist in the compilation of (parts of) your STED files, compliant to the IVDR:
  • Classification of your devices
  • GMDN and GIVD codes
  • General Safety and Performance Requirements with indication of applicable harmonized standards
  • Risk Assessment
  • Performance Evaluation documentation:
  1. Scientific Validity Report, incl. extended Literature Study
  2. Clinical Performance Report based on Clinical Performance Studies, Literature Study and experience gained by routine testing
  3. Analytical Performance Report, based on Analytical Performance Studies
  • CLP classification of IVD reagents and compilation of SDS according to REACH
  • Post Market Surveillance, including PMPF (post market performance follow-up)
  • Declaration of conformity

Contact us to get more information about how Qarad can assist you!

Qarad can help!

Contact us if you need help in the compilation of (parts of) your STED!


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