Medical device clinical evaluation requires specific expertise combining command of regulatory requirements, methodological rigour and an understanding of the technical challenges specific to health products. Pharmaspecific supports manufacturers, medtech start-ups, sponsors and industrial partners in conducting device clinical investigations and post-market studies in Europe. These clinical evaluations document the safety, performance and compliance of medical devices throughout their development.

Our teams are involved at every stage of the project to ensure regulatory compliance, clinical data quality and compliance with the requirements applicable to medical devices and in vitro diagnostic medical devices.