Performance Evaluations for In Vitro Diagnostics - IVD

According to Common Technical Specifications

The In Vitro Diagnostics listed in Annex II List A of the IVD Directive must be evaluated according to the Common Technical Specifications on a population that is representative for the European population.

Qarad organizes such performance evaluations in collaboration with Europe‚Äôs most renowned evaluation centers. The resulting report, issued by these evaluation centers, will be accepted by your Notified Body. Our service includes all the communication with the evaluation center, evaluation protocols, monitoring of the study, notification of the study and the writing of the performance evaluation chapter for your design dossier of your IVD. 

Contact us for more details on performance evaluations on In Vitro Diagnostics - IVD.

Other performance evaluations

When you want performance evaluations done on European populations, we can assist you in the organization of the studies.

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Performance evaluations