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
