Clinical Investigation is a systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device. Clinical Evaluation Center for Devices (CECD) undertakes an extensive clinical investigation and documents the entire process efficiently.
Clinical evaluation is mandatory for initial CE-marking and it must be actively updated thereafter. The Clinical Evaluation Center for Devices (CECD) takes care of the complete clinical evaluation process with ease!
The core success of Medmonts CECD lies in adhering to the compliance of both EU MDR 2017/745 and MEDDEV 2.7.1 Rev 4, thereby ensuring the safety and performance of the medical device that is evaluated.