From idea to safe medical device
Development of medical devices is a complex process taking place in a highly regulated environment. Besides specific technical expertise in this area, compliance with the relevant regulatory requirements is of pivotal importance. In this environment, we conduct research, development projects, and device testing. Our Translational Biomedical Engineering team has many years of experience in the development of medical devices. The focus is on neuro-implants on the one hand, and on conducting and assisting the development of novel technologies for administration of medical aerosols on the other hand.
Close dovetailing with the institute’s other working groups with scientific or medical focuses allows the team to provide comprehensive support to clients in their development projects. By cooperating with both internal and external development partners from industry and academia, we quickly find flexible solutions for project-specific requirements. In the area of quality and risk management, we support qualification of external technology processes for medical devices.
For inhaled administration of medical aerosols, we develop novel technologies or assist our clients in their development activities. In addition, our scientists deal with issues arising during development of novel formulations. Our portfolio ranges from dealing with physical and physicochemical problems in the area of aerosol technology to providing assistance in the performance of necessary preclinical and early-phase clinical studies.
In the field of neuro-implants, we collaborate with our clients to develop methods tailored to specific needs, to ensure safety and functionality of advanced implants in compliance with EN ISO 60601/EN ISO 14791. Our portfolio also comprises novel accelerated-aging procedures especially designed for human life span polymer active implants, with acceleration factors of 490 and more.