Performance Evaluation Studies

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Does your IVD device require appropriate clinical evidence? With regard to your IVD Performance Evaluation Studies, we are glad to assist you.

Are you looking for a qualified partner to produce accurate and reliable clinical proof for your IVD device that complies with all relevant rules and guidelines?

We are delighted to assist you with your IVD Performance Evaluation Studies thanks to our IVD experts. Please get in touch with us if you want more details.

WHAT ARE IVD PERFORMANCE STUDIES?

Protecting the safety of IVD formulations and their performance

The accuracy, precision, sensitivity, specificity, and reproducibility of a diagnostic assay or test system, as well as its analytical and clinical performance, are evaluated through IVD (In Vitro Diagnostic) performance assessment studies. These investigations may make use of well-known samples or specimens, and the outcomes are contrasted with a gold standard or reference technique. The ISO and WHO standards must be met by manufacturers in order to protect the security and effectiveness of IVD devices. In order to produce high-quality clinical evidence to show the performance of IVD devices, MedWatch Global provides analytical and clinical performance studies in cooperation with renowned clinical labs, blood banks, and cutting-edge private services.