Platform for Clinical Trials

The Platform for Clinical Trials offers a comprehensive range of services tailored to the specific needs and requirements of internal and external partners. Our expertise covers the entire clinical trial process - from consulting on study design and study concepts, as well as strategic aspects of study planning and operational implementation, to the preparation of all relevant documentation required for the application and conduct of clinical investigations.

We manage submissions to Ethics Committees and, where applicable, to competent national authorities. The Platform for Clinical Trials ensures the successful execution of clinical trials in full compliance with Good Clinical Practice (GCP), particularly EN ISO 14155:2026, the internationally recognised standard for clinical investigations of medical devices, as well as 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 EN ISO 20916:2019, the internationally recognised standard for performance studies involving in vitro diagnostic medical devices.

Beyond study execution, we offer comprehensive scientific and statistical analysis of study data. The preparation of the final study report, and expert guidance on the publication of study results, makes the Platform for Clinical Trials a full-service partner for the conduct of clinical trials. Through its Platform for Clinical Trials, Fraunhofer IMTE serves as a strategic partner that intelligently connects research, development, and clinical investigation, thereby sustainably strengthening the innovation capacity and competitiveness of the industry.

Fraunhofer IMTE provides access to a wide range of infrastructures that can be utilised directly along the entire value chain. These include the Lübeck Innovation Hub for Robotic Surgery (LIROS) for robot-assisted surgery, the SimVitro Platform for Biomechanical Simulation, an accredited testing laboratory for non-destructive testing (particularly in the fields of additive manufacturing and titanium printing for implants), and a state-of-the-art platform for AI-supported gait analysis.

With its Platform for Clinical Trials, Fraunhofer IMTE bridges the gap between research and practical application. The platform serves as a central point of contact for all aspects of clinical investigations involving medical devices - offering independent expertise, a strong regulatory foundation, and dedicated support to enhance the innovative strength of industry partners.

As a non-profit research organisation, Fraunhofer is committed to responsibly transfer scientific knowledge into practical applications. By combining research, development, and clinical investigation, Fraunhofer IMTE acts as a strategic partner that sustainably strengthens the innovation capacity and competitiveness of the industry.

Advantages of Collaborating with Fraunhofer IMTE

Neutrality – High level of acceptance and credibility with regulatory authorities, Ethics Committees, and funding organisations.

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

Network access – Connecting industry partners with hospitals, universities, and research institutions.

Risk minimization – Systematic management of regulatory, compliance, and liability-related risks.

Sustainable partnership – Support throughout the entire value chain, from the initial idea and product development to clinical investigations prior to market approval and research-driven Post-Market Clinical Follow-up (PMCF) studies following market approval.