Clinical and Regulatory Affairs


© iStock
© iStock

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.


  • Regulatory-scientific product delineation and classification
  • Development and implementation of regulatory strategies
  • Selection and monitoring of conformity assessment and approval procedures with a focus on personalised medical devices including IVDs
  • Identification of applicable standards and their interpretation
  • Assessment and design of quality management systems/integrated management systems including risk management
  • Offers for further education and training in the field of regulatory affairs
  • Support in planning and conducting clinical trials of medical devices
  • Conceptual design of post-market clinical follow-up (PMCF) studies
  • Review and optimisation of the usability of medical devices
  • Clinical needs analysis in the field of implants and instruments
  • Compliance-oriented integration of clinical expertise