Clinical & Regulatory Affairs

Fraunhofer IMTE has outstanding expertise in the field of medical technology in accompanying the processes from the product idea up to patient use. By closely linking the areas of Clinical and Regulatory Affairs, we can provide optimal support beginning with product development to market launch and post-market surveillance (PMS/PMCF). 

Together with the customer, we develop a project plan set up for the specific product in order to ensure compliance with regulatory requirements already during the design phase. In addition, we develop regulatory strategies as well as study designs for clinical trials (investigations) including essential documentation for a successful submission to the ethics committee and competent authorities. 

With our expertise we want to be an interdisciplinary partner for our clients and support them in finding an optimal path for conformity assessments/approvals.



Clinical Affairs

We support you in the planning and realization of clinical trials and investigations, including the compilation of a study design with all required regulatory documentation.

Regulatory Affairs

We support you in the development and implementation of regulatory strategies for medical devices, including personalized medical devices and IVDs, and provide support with our expertise in the field of standardization.