Safety and risk assessment

© Fraunhofer ITEM

Risk management:

The clinical use of medical devices requires that this use poses no risk to the safety and health of patients and device users. Risk management, therefore, plays a pivotal role in the development phase, not only to comply with the relevant guidelines. Based on our experience, we support our partners throughout the development phase in minimizing any risks in compliance with the relevant standards.


We support our partners with our expertise in the development and implementation of safety features, the formal implementation of risk management, and any risk mitigation measures that may be required.