Performance Studies for In Vitro Diagnostics
To comply with the EU IVD Regulation 2017/746, a Performance Evaluation shall consist of:
Qarad can provide you with the complete package or parts of it.
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:
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.
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.