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Clinical evaluation

A obligation of manufacturers of medical devices is to conduct a clinical evaluation. The extent of the clinical evaluation is dependant upon the exact specifications, intended use and used materials of the medical device. Obviously, a more extensive clinical evaluation is required for invasive device than devices that only come into contact with intact skin.

The results of the clinical evaluation shall be reported in a clinical evaluation report (hereafter: CER). The CER shall be part of the Technical Documentation which shall be compiled by the manufacturer. This report shall include both favourable and unfavourable data.

Clinical Evaluation

CE Medical

Are you bringing a medical device onto the European market? It is a legal obligation of the manufacturer to conduct a clinical evaluation. CE Medical can assist you with shaping the clinical evaluation and drawing up of the CER.

Contact one of our experts now to discuss the possibilities regarding your CLINICAL EVALUATION plans.