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.