Regulatory Affairs

To address regulatory aspects throughout the entire product life cycle of medical devices including in vitro diagnostics (IVDs), Fraunhofer IMTE is available as an interdisciplinary partner for a wide range of organizations (SMEs, large organizations, R&D, industry, etc.) in the area of Regulatory Affairs.


Our range of services includes:

  • Regulatory-scientific product demarcation and classification
  • Development and implementation of regulatory strategies
  • Selection and support of conformity assessment and approval procedures with a focus on personalised medical devices including IVDs
  • Identification of applicable standards and their interpretation
  • Evaluation and conceptual design of quality management systems/integrated management systems including risk management
  • Offers for further education and training in the field of regulatory affairs


Please feel free to contact us with your questions.