Analytical Study Services

Analytical studies are crucial element in the development of the medical and in vitro diagnostic devices in compliance with the corresponding European regulations. It is the first step of the device performance at the premarket phase. Parameters such as sensitivity, specificity, cross-reactions, interferences, and type of the different specimens and its composition are all tested against the performance of your device. Requalite with its partner Analytical testing Lab in Germany is providing you all required testing and analysis. We also help our clients to develop appropriate assays, test methodologies, and instrumentation to obtain best possible analysis results for their analytical device testing as required by MDR/IVDR/FDA and other global regulatory bodies.