From basic research to clinical testing of medical devices
Our commitment is to close the gap between basic research and first clinical trials with particular emphasis on safety aspects – regarding regulation, quality assurance and manufacturing technology. In cooperation with partner institutions we cover the whole chain from innovation to a CE-compliant product.
We equip companies and entrepreneurs with the technical and regulatory support that will allow their innovations to enter and pass clinical testing. This includes dedicated manufacturing processes that commonly represent substantial economic hurdles for companies. These processes can be provided by our partners and are pooled within the High-Performance Center with corresponding quality and risk management structures for medical devices, supplemented by appropriate process logistics to provide a one-stop shop. In addition, we guide clients along the regulatory pathway including necessary documentation, arrange or conduct the required tests and optimize these according to the requirements of the innovation in close contact with the notified body.
In our research cooperation network we link biomedical engineering to the strengths of Fraunhofer ITEM, in particular in the fields of aerosol technology and biocompatibility, and those of the partners in the Center in the fields of physics, chemistry, biology, engineering sciences, and materials sciences. With an emphasis on polymers and micro/nanotechnology, we enable realization of sensor-based and actuator-based solutions for medicine, environmental technology, and for habitat safety.
The core competencies of the center for implants and inhalation technology are systematically developed towards smart drug/device combination products.