TED-MeD Launches: Empowering MedTech SMEs With AI-Driven Safety & Compliance
CertHub, Modelwise, and FAU have launched TED-MeD, a research project funded by €956,832 to help MedTech SMEs streamline development and compliance. With an AI assistant and process model, the project aims to speed up certification and bring safer devices to market faster.
The future of medical device development just got a major boost. Today, we’re proud to kick off TED-MeD (Trusted Engineering Design for Medical Devices)—a collaborative research project between Modelwise GmbH, CertHub GmbH, and the Friedrich-Alexander University Erlangen-Nürnberg (FAU).
Backed by €956,832 in funding from the Bavarian Research Foundation, TED-MeD is designed to help small and medium-sized MedTech companies navigate the complexities of product development and regulatory approval with confidence.
What TED-MeD Solves
Developing medical devices under the EU MDR (Medical Device Regulation) is more demanding than ever. With cutting-edge technologies like AI and robotics becoming standard, compliance and safety challenges multiply—especially for teams without dedicated regulatory departments. These delays can hold back life-changing innovation.
TED-MeD changes that. The project combines a MedTech-specific development framework with an AI-powered assistant that proactively supports risk identification and compliance from day one. The result? A structured, efficient path from concept to certification.
CertHub’s Role: Turning Regulation into Acceleration
At CertHub, we specialize in helping companies navigate complex certification and regulatory landscapes. Within TED-MeD, we ensure that every step of the process meets MDR and international standards—without slowing innovation down.
Real-World Impact: From Theory to the Operating Room
To demonstrate TED-MeD’s full methodology in action, the project includes the development of a robotic catheter system for minimally invasive vascular procedures. This high-tech use case combines AI, robotics, and compliance to show how iterative design and early risk detection can drastically reduce time-to-market—without compromising safety.
TED-MeD brings together leading forces in MedTech:
Modelwise GmbH (Munich): Specialists in automated functional safety analysis, helping teams reduce risks and accelerate development. FAU/SPARC, led by Prof. Dr. Franziska Mathis-Ullrich: A leading research lab in AI, robotics, and translational biomedical engineering. CertHub GmbH: Experts in regulatory processes, compliance, and certification strategy for medical devices.
TED-MeD represents a new era of smarter, safer medical device development. Together, we’re creating the tools and processes that help bring innovation to patients faster—without compromising on quality or compliance.
Want to learn more or follow our progress? Reach out to us!
