Clinical Evaluation Report & Clinical Study

Clinical evaluation of medical devices

Clinical evaluation is a critical component in the regulatory pathway for medical devices, serving as the foundation for demonstrating safety, performance, and clinical benefit. With the increasing complexity of regulatory requirements under the EU Medical Device Regulation, comprehensive Clinical Evaluation Reports (CERs) and high-quality clinical studies are more important than ever.

Our approach combines in-depth regulatory knowledge with practical experience in clinical evaluation and clinical investigation. We support medical device manufacturers in systematically assessing clinical data, identifying data gaps, and, when necessary, designing and conducting compliant clinical studies. All activities are aligned with current MDR requirements.

Whether you are launching a new product or maintaining compliance for an existing device, we provide strategic and operational support throughout the entire clinical evaluation process.