Regulatory support in translational biomedical engineering

We take care of your regulatory strategy and relevant processes for market approval – tailored to your specific requirements

An important pillar for success in the development of medical device technology is the regulatory strategy. The earlier this strategy is established, the shorter the time to market. During startup, the focus is frequently on other important questions; therefore, we offer early support to address relevant regulatory issues, especially to small enterprises and startups.

This support includes assistance in the selection of an approval strategy, implementation of this strategy, and workshops to sensitize for processes and documentation necessary for market approval. Other support services tailored to your specific requirements are also available upon request.

Fraunhofer ITEM assists manufacturers with implementing the new EU regulation on medical devices

The new EU-wide Medical Device Regulation (MDR) became effective in 2017, entailing consequences for manufacturers of medical devices. Among other obligations, they are required to provide more documentation to comply with the new legislation. The expertise pooled at Fraunhofer ITEM, in particular in the Division of Translational Biomedical Engineering, enables comprehensive support in the implementation of the new regulation.

Fraunhofer ITEM provides optimal support in developing innovative biomedical engineering solutions in compliance with the new regulations and in implementing the new requirements. Read more

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.

Mitigation:

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.