The Clinical and Regulatory Affairs department of the Fraunhofer IMTE has outstanding expertise in the field of medical technology including in vitro diagnostics in accompanying the processes from the idea to the application on the patient. Due to the close link between the areas of Clinical and Regulatory Affairs, we are able to provide optimal support from development through market launch to monitoring on the market (PMS/ PMCF).
Together with the client, we develop a project plan adapted to the respective product in order to ensure compliance with regulatory requirements already during the design phase. Furthermore, we develop approval strategies as well as study designs for clinical trials including essential documentation for a successful submission to the ethics committee and the competent authorities
With our expertise, we want to be available to our clients as an interdisciplinary partner and support them in finding an optimal path for conformity assessment/approval.