AI-enhanced Systems Engineering for the Development of complex Medical Devices

The highly innovative European medical technology sector suffers from increasing requirements regarding legislation. New regulations, such as the Medical Device Regulation (MDR), cause additional requirements and certification efforts, leading to additional manual documentation efforts during development and delaying innovations. At the same time, generative Artificial Intelligence (AI) offers great potential for support and automation in development processes. Therefore, we aim to integrate and leverage these new possibilities of generative AI in the existing Systems Engineering methods, facilitating higher efficiency and quality in development. As an application domain, we focus on the medical technology sector.