Regulatory and Clinical Affairs

At the Regulatory and Clinical Affairs Competence Center at Fraunhofer IMTE, innovative medical technology developments receive comprehensive regulatory support from the initial idea through to clinical validation.

In view of growing technological innovations and regulatory requirements, it is crucial to have a partner who understands the scientific and practical challenges in the field of medical technology research and development. In this context, the Competence Center for Regulatory and Clinical Affairs plays an important role, acting as a bridge between science, industry, and regulation.

The Competence Center offers comprehensive scientific and regulatory support throughout the entire product life cycle – from the initial idea, through its regulatory classification, research and development according to the “compliance by design” principle, validation using a variety of Fraunhofer IMTE test platforms, to research-centered evidence generation after market launch. This is achieved through a combination of expert knowledge, regulatory strategy, and customized research and development services, which can also be provided in collaboration with other Fraunhofer Institutes. In this way, research institutions and small and medium-sized enterprises (SMEs) are to be comprehensively and purposefully empowered to drive innovation while mastering complex regulatory requirements.

• Development and implementation of regulatory strategies for research and development projects according to the “compliance by design” principle
  • Product differentiation and classification according to MDR / IVDR
  • Identification of applicable standards / harmonized norms
  • Design of quality management systems/integrated management systems including risk management
• Planning, conducting, and evaluating clinical studies and clinical trials
  • Definition of main objectives and hypotheses, study design, inclusion/exclusion criteria, case number planning, risk management, etc.
  • Selection of suitable study centers and data collection systems, training of personnel, implementation of monitoring activities
  • Data analysis and interpretation in response to scientific questions, preparation of final reports, publication of results if applicable
• Compliance-compliant integration of clinical expertise
• Research project-related support for further regulatory requirements, e.g., from GDPR and AI Act