Regulatory and Clinical Affairs

At Fraunhofer IMTE, companies are supported in the development, regulatory assessment, and approval of medical devices. The focus is on customized solutions for clinical trials, approval strategies, and post-market measures.

In the area of Clinical and Regulatory Affairs, Fraunhofer IMTE offers comprehensive scientific and regulatory support throughout the entire product lifecycle – from the initial idea to clinical application. A particular strength lies in the integration of regulatory, clinical, and quality-relevant expertise in the field of medical technology, including in-vitro diagnostics.

Small and medium-sized enterprises (SMEs) are supported in the development of individual approval strategies, the design of clinical trials, and the creation of the necessary regulatory documentation. The goal is always to successfully submit to ethics committees and competent authorities. During the design phase, project-specific plans are developed to consider regulatory requirements early on.

Furthermore, professional support is provided in the planning and execution of clinical studies, usability tests, and measures under post-market surveillance (PMS) and clinical follow-up (PMCF). In the context of conformity assessment and approval of medical devices, practical and sustainable solutions are developed.

• Regulatory-scientific product delineation and classification
• Development and implementation of regulatory strategies
• Selection and monitoring of conformity assessment and approval procedures with a focus on personalised medical devices including IVDs
• Identification of applicable standards and their interpretation
• Assessment and design of quality management systems/integrated management systems including risk management
• Offers for further education and training in the field of regulatory affairs
• Support in planning and conducting clinical trials of medical devices
• Conceptual design of post-market clinical follow-up (PMCF) studies
• Review and optimisation of the usability of medical devices
• Clinical needs analysis in the field of implants and instruments
• Compliance-oriented integration of clinical expertise