Regulatory requirements are often considered complex and difficult to understand. However, with the right expertise and clear communication, even challenging content can be presented in a practical and understandable way.

The TRAIN Academy has welcomed two new speakers who embody this approach: Dr. Carina Mennenga and Dr. Brigitta Révész-Walker. In their presentation, “Roadmap to Clinical Evaluation of Medical Devices,” they provided a clear and well-founded overview of the Medical Device Regulation (MDR) requirements for the clinical evaluation of the safety and functionality of medical devices.

The speakers explain the regulatory requirements, processes, and legal framework in a structured, understandable manner. Their practical examples from daily work at MDSS Consulting GmbH particularly stood out, impressively illustrating the relevance of the content in the real regulatory environment. There, they provide comprehensive support to national and international customers on regulatory issues relating to medical devices.

Their presentation demonstrates how expertise, experience, and clear communication can make regulatory issues tangible.

We are pleased that these two experts have joined the TRAIN Academy!