Platform for Clinical Trials

The Clinical Trial Platform provides a broad range of services tailored to the individual needs and requirements of internal and external partners. Services range from consulting on study design and study concepts as well as strategic questions related to study planning and operational implementation, to the preparation of all relevant documentation required for the application and conduct of clinical trials.

Obtaining approvals from the ethics committee and, if required, the competent federal authority, is also part of the service portfolio. Furthermore, the entire conduct of clinical trials is ensured in accordance with Good Clinical Practice (GCP) – in particular the EN ISO 14155:2020 standard, which was specifically designed for clinical investigations of medical devices – and the Medical Device Regulation (MDR) 2017/745. Performance studies involving in vitro diagnostic medical devices are conducted in accordance with Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) and the relevant standard EN ISO 20916:2019, which was developed specifically for performance studies involving in vitro diagnostic medical devices.

After completion of the clinical trial, the scientific and statistical evaluation of the study results can also be carried out through the Clinical Trial Platform. The preparation of the final study report, as well as further consultation on the publication of study results, makes the Clinical Trial Platform a full-service partner for the conduct of clinical trials. With its Clinical Trial Platform, Fraunhofer IMTE acts as a strategic partner that intelligently connects research, development, and clinical investigation – thereby sustainably strengthening the innovation and competitiveness of industry.

At Fraunhofer IMTE, numerous infrastructures are available that can be utilized directly along the value chain. These include the Lübeck Innovation Hub for Robotic Surgery (LIROS) for robot-assisted surgery, the Biomechanical Simulation Platform (SimVitro), an accredited testing laboratory for non-destructive testing (particularly in the field of additive manufacturing and titanium printing for implants), and a modern platform for AI-based gait analysis.

With the Clinical Trial Platform, Fraunhofer IMTE creates a bridge between research and application. It establishes a central point of contact for all questions related to the clinical investigation of medical devices – neutral, regulatorily sound, and dedicated to strengthening industrial innovation capacity.

As a non-profit organization, Fraunhofer is committed to responsibly transferring scientific knowledge into practice. Acting as a strategic partner, it strengthens the innovation and competitiveness of industry by linking research, development, and clinical investigation.

Advantages of Collaborating with Fraunhofer IMTE

Neutrality – high acceptance among authorities, ethics committees, and funding bodies

Scientific excellence – integration of regulatory and clinical expertise within a strong research environment

Network access – bridges to hospitals, universities, and industry partners

Risk minimization – systematic management of regulatory and liability-related risks

Sustainable partnership – support along the entire value chain, from the initial idea through development to clinical investigations prior to market approval (CE marking) and research-driven Post-Market Clinical Follow-up (PMCF) studies after market approval.