Clinical and analytical performance studies

Performance Studies for In Vitro Diagnostics

Performance studies for In Vitro Diagnostics

To comply with the EU IVD Regulation 2017/746, a Performance Evaluation shall consist of:

  • a Scientific Validity Report based on literature review;
  • 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.


Qarad can provide you with the complete package or parts of it.

Clinical Performance studies

Qarad organizes clinical performance studies in collaboration with Europe’s most renowned evaluation centers and blood banks. 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, drafting evaluation protocols, monitoring the study, data evaluation and writing of the clinical performance study section for the technical documentation of your IVD.

All studies can be designed to conform to the applicable standards, for example:

  • Common Technical Specifications for Annex II, list A products
  • CLSI standards
  • WHO standards

 

Our studies will be conducted in line with the standard ISO 20916:2019 (in vitro diagnostic medical devices – clinical performance studies using specimens from human subjects – good study practice), and will comply with the national or regional requirements for ethics committee approval.

Analytical Performance studies

Qarad organizes performance studies to verify the analytical performance of your In Vitro Diagnostics (precision accuracy, sample stability, …) in collaboration with high standard private labs.

Contact us for more information

Qarad IVDR Conference 2022

NHOW Brussels

October 11-13

Get the latest IVDR insights during our three-day conference, including a pre-conference workshop.