Cybersecurity Training for Medical Device Compliance

This document is a case study detailing the cybersecurity training program provided by infoteam Software Group for LRE Medical GmbH, a manufacturer of diagnostic devices. The training was designed to enhance knowledge and improve development processes in the context of increasing regulatory requirements, particularly the IEC 81001-5-1 standard for cybersecurity in medical technology. The program included a two-day training course that combined theoretical knowledge with practical exercises, covering essential topics such as regulatory requirements, secure software life cycle, threat modeling, security testing, and SBOM vulnerability monitoring. A follow-up Q&A session was conducted to reinforce learning and address practical questions. As a result of the training, LRE Medical employees can now create necessary safety certificates more efficiently, reducing internal costs and enhancing their market position. The improved quality of documentation also increases LRE’s attractiveness as a reliable supplier, contributing to a sustainable competitive advantage.