Regulatory support in translational biomedical engineering

We support you in creating the technical documentation for your medical device and guide you through regulatory processes tailored to your individual requirements. This ensures that the general safety and performance requirements for your product are met, paving the way for a successful conformity assessment and CE marking.

A critical factor in the development of medical devices is a complete technical documentation that provides evidence of the essential safety and performance requirements and serves as the foundation for successful conformity assessment. Medical devices can only enter the European market with a declaration of conformity, which may be issued after a successful conformity assessment.

The current European regulations, MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation), mandate requirements for the safety and quality of medical devices and are essential for market entry. The technical, biological and chemical risks must be determined and assessed for the entire life cycle of a medical device. The "Biomedical Engineering" department combines medical device expertise with years of experience in assessing chemicals, nanomaterials, and biocompatibility.

• Support and guidance: We assist medical device manufacturers in developing new medical innovations or adapting existing products to meet current requirements.
• Quality management: support in setting up in accordance with ISO 13485 for start-ups and spin-offs.
• Customized strategies: Together with our clients, we develop individualized strategies, applying relevant standards or preclinical tests to bring their medical device to market.
• Risk assessment: We develop risk management according to ISO 14971, conduct a safety assessment of the medical device as part of the risk management process, and identify, develop, or connect with tailored in vitro and in vivo testing within our Fraunhofer network.
• Technical documentation: We help you compile comprehensive technical documentation.
• Network: We are part of the MDR Competence Network and collaborate with other excellent partners in areas like in vitro testing, clinical trials, biological assessment, additive manufacturing and analytical methods. Additionally, Fraunhofer ITEM is part of the Fraunhofer Group for Health.