Clinical Evaluation

Clinical evaluation is a continuous and methodological process that aims to collect, analyze and evaluate clinical data relating to a medical device for proving compliance with the general requirements of safety and performance according to the intended use.  The methods for collecting, analysing and evaluating clinical data are different and must be tailored to the medical device being evaluated. For this reason, Cebis applies specific internal procedures developed for the study of the medical device, in order to propose in the Clinical Evaluation Plan the best methodology for collecting, analyzing and evaluating clinical data for the medical device that will be developed in the Clinical Evaluation Report. Cebis strictly applies the requirements of Regulation (EU) 2017/745 Annex XIV to ensure its customers the required compliance.