Clinical evaluation

A clinical evaluation is an important link between the technical file and clinical investigation. We develop the required clinical evidence for your medical device. According to the MDR, a medical device manufacturer‘s QMS must address clinical evaluation.

Clinical evaluation plan and report

Clinical evaluation is a systematic and continuous process to validate the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer. We produce plans and deliver reports ensuring consistency with your intended purpose, claims and technical documents.