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.

Clinical data strategy

A clinical data strategy shows how the investigations support the claims with needed clinical evidence and that your resources are allocated and focused. A carefully planned strategy from product development to the post-market phase can bring your device to market faster and supports marketing efforts for commercialization and a successful launch.

Clinical evaluation SOP

After assessing your type of device and internal processes, we compose a Standard Operating Procedure (SOP) that is the best fit for your device and processes.