Performance evaluations for Medical Devices and In vitro Diagnostic Devices
Part of performance evaluations in Europe, the USA and China is to search, collect and evaluate the available scientific literature using a systematic search approach. MARACA International can perform such a systematic review of the scientific literature and provide a performance evaluation plan and report. This report will identify the gaps in clinical evidence for your product and guide the development of a clinical study plan when needed.
When a clinical study is needed, MARACA International can help develop the Clinical study plan/protocol, manage data collection, monitor the study and generate the clinical study report. We will notify your study when needed and help write the performance evaluation chapter of your design dossier.
More detailed information? We are happy to learn more about your products and their clinical evidence needs to make a proposal.