Press Release | Munich, Germany – April 7th, 2025
Modelwise, CertHub & FAU Erlangen-Nürnberg join forces to launch AI-powered design & compliance assistant for SME Medtech
Today, we kicked off the research collaboration project Trusted Engineering Design for Medical Devices (TED-MeD) between Modelwise GmbH, CertHub GmbH and Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU). Our goal with TED-MeD is to streamline both device development and regulatory approval, critical hurdles particularly for small and medium sized- enterprises (SMEs) by combining an AI-based- interactive assistant with a Medtech specific process model for early safety risk identification and compliance support for complex medical regulations.
The Bayerische Forschungsstiftung selected TED-MeD out of a highly competitive group of proposals to fund the project with €956.832 supporting our mission to accelerate Medtech innovation translation from research into clinical practice.
TED-MeD’s holistic approach
Medical device development under the EU Medical Device Regulation (MDR) is an expensive and time -consuming process. The adoption of advanced technologies, such as AI-powered- robotics, further increases the complexity, time, and cost of safety testing and certification. As a result, many promising products reach the market later than they could, leaving potentially transformative patient benefits unrealized.
The TED-MeD project directly tackles these issues. By combining a comprehensive process model tailored to Medtech and an interactive assistance system for developers, the project will help teams incorporate safety and compliance related considerations at every stage—from initial design through final certification. This support is particularly transformative for companies without extensive in-house regulatory expertise, ensuring the design process remains structured, efficient, and focused on product safety.
“TED-MeD paves the way for safer, more cost -effective medical device development. By embedding compliance and safety early, we empower SMEs to bring life-changing solutions to patients faster.”
Prof. Franziska Mathis-Ullrich (FAU/SPARC)
Demonstrator: Robotic Catheter Manipulator
One of the project’s key aims is to develop a novel AI-driven robotic catheter manipulator for endovascular procedures. With this demonstrator we showcase TED-MeD’s integrated methodology in a real-world context with all its technical complexities of cutting-edge medical technology. By applying proactive risk detection and iterative design refinements, the consortium aims to reduce time-to-market while preserving the highest safety standards.
Partners in innovation
Together with CertHub and the Laboratory for Surgical Planning and Robotic Cognition (FAU/SPARC), headed by Prof. Dr. Mathis-Ullrich at Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), we are advancing the development of innovative medical technology. FAU/SPARC stands out for its cutting-edge research in the fields of AI, robotics, and translational biomedical engineering, delivering essential insights for pioneering medical solutions. CertHub contributes extensive expertise in certification and regulatory processes, ensuring that the products developed meet the requirements of the MDR and other international guidelines. Last but not least, we contribute our proven experience in automating functional safety analysis that is already reducing product risks whilst accelerating the development process, getting safer products to market quicker for customers today.
“For TED-MeD we pool technological innovation, certification know-how and academic rigor. TED-MeD will significantly reduce the hurdles Medtech developers face, from concept to compliance, ensuring patients benefit sooner from groundbreaking devices.”
Claudius Jordan (Senior Engineer Modelwise)
About Modelwise:
Modelwise, a Munich-based deep-tech company, revolutionizes functional safety analysis. Its solution integrates seamlessly into engineers’ workflows, reducing time-to-market and ensuring the safety of critical products.
About CertHub:
CertHub GmbH provides expert guidance on medical device certification and regulatory processes. Its services help companies navigate MDR and global compliance requirements efficiently.
About FAU/SPARC
The Laboratory for Surgical Planning and Robotic Cognition (SPARC) at Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) pioneers research in AI, robotics and biomedical engineering, driving the translation of cutting edge- technologies into healthcare solutions.
For media inquiries or further information, please contact:
Claudius Jordan, claudius.jordan@modelwise.ai, +49 89 2500 79 83 0
