Technical Documentation

Compilation and review of your STED files

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:
    • Scientific Validity Report, incl. extended Literature Study
    • Clinical Performance Report based on Clinical Performance Studies, Literature Study and experience gained by routine testing
    • 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 for more information