Fraunhofer IMTE provides support in the area of clinical affairs for medical devices during the complete life-cycle from the development phase through their approval to their post market surveillances in accordance to the applicable laws.
Our services in the area of Clinical Affairs include:
- Support in planning and conducting of clinical trials for medical devices
- Design of post-market clinical follow-up (PMCF)
- 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.