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
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
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