Furtwangen University teaches the next generation of medical device experts using Aligned Elements

Professor Mike Fornefett aims to prepare his students for the workforce by teaching modern software tools and processes through a hands-on approach. Before joining the University of Furtwangen, Prof. Fornefett spent over a decade with hands-on medical device development.

His graduates leave the master’s program well-prepared to tackle real-world medical device development challenges using state-of-the-art technology.

As part of this modern approach to medical device engineering, Prof. Fornefett instructs his students on using Aligned Elements as an example of a modern software tool for Design Control Management and Technical Documentation.

Moreover, he tracks the progress of his students' work using the same software.

Medical Devices - Regulatory Affairs Master: A Degree for the Future

To address the medical device industry’s rapidly increasing demand for highly trained professionals, this program focuses on the approval of medical technology products, process and quality management, and development processes in the field of medical devices. This master's degree can be completed in five semesters while working.

Tackling Medical Device Development Challenges Hands-On

After studying several in-depth modules covering both regulatory and development aspects of medical device development, students can focus on IT tools in regulatory affairs. Here, they solve practical tasks using the application lifecycle management tool Aligned Elements. By addressing design controls throughout the product lifecycle and by managing regulatory documents, students gain comprehensive familiarity with the complexity and interdependencies of medical device development documentation, as well as the strategies and tools available to streamline these tasks.

 “When it comes to training, it is important to our team that we teach the legal and normative principles, but also methods of how something can be implemented, for example risk management for medical devices.

The third pillar is practice, in which we look at the implementation using various IT tools together with the students and also practice some of them. We are grateful to Aligned for their support here.”, says Professor Fornefett.

 How Aligned supports Furtwangen University

"Ensuring that medical device professionals are thoroughly trained in both regulations and state-of-the-art tools is paramount to advancing healthcare and patient safety. We are thrilled to support the University of Furtwangen in this endeavour, to equip the next generation of experts with the skills they need to successfully develop the next generation of medical devices.", adds Karl Larsson, Managing Director, Aligned AG

Find out more at: Expertise in the approval of medical products (hs-furtwangen.de)