Performance studies

According to the EU Regulation on in vitro diagnostic products, an IVD Performance evaluation should consist of three aspects:

• Scientific Validity Report
• Clinical Performance Studies
• Analytical Performance Studies

Qarad can provide you with complete or partial Performance Evaluation Documentation.

Our complete package, compliant to the IVD Regulation 2017/746 consists of:

• A Performance Evaluation Plan and a Performance Evaluation report
• A Scientific Validity Report based on an in-depth literature study
• An Analytical Performance Report based on analytical performance studies
• A Clinical Performance Report based on literature review, clinical performance studies or data of routine use