Medical Affairs

Fraunhofer IMTE provides support in the area of medical affairs for medical devices during the complete life-cycle from the development phase through their approval to their post market surveillances regarding the applicable laws. 

 

Our services in the area of Medical Affairs include:  

  • Support in planning and performing of clinical trials for medical devices
  • Design of post-market clinical follow-up (PMCF) trials
  • Regulatory strategies for medical devices and advanced therapy medicinal products (ATMPs)
  • Review and optimization of usability of medical devices
  • Clinical needs assessment in the field of implants and instruments
  • Compliance-conformal integration of clinical expertise

 

Please contact us to discuss your project ideas and learn more about our services.