Based on in depth literature review
As per IVD-Regulation 2017/746, the performance evaluation of an IVD Medical Device consists of three pillars:
Qarad can provide you with the complete Performance Evaluation
documentation package or one or multiple parts.
Click here for more information about the Analytical and Clinical performance Studies.
Scientific validity is concerned with the association of the analyte of a device with one or more clinical conditions or physiological states (Regulation 2017/746, Art. 2, definition 38). This association is a fundamental factor in the justification process for development and production of IVD devices.
At Qarad, we can provide you with scientific validity reports that follow the procedures as stipulated by the IVD Regulation (Annex XIII, 1.2.1). The service is entirely based on a systematic literature study and involves:
We have created Scientific Validity Reports for many reputable companies before.
See our fact overview below.
Qarad has many years of experience in European IVD Regulations, which allows us to understand the bigger picture.
We can provide you with a complete documentation package with your performance evaluation:
We follow your specific demands and are in constant interaction to fulfill your needs.
We make sure that the quality and content of the Scientific Validity Reports is consistent and does not depend on the individual visions of each expert within the company.
Avoid overwhelming your employees with the excessive work which comes with the pressing demands of the new IVD regulation.