sitem Center for Translational Medicine and Biomedical Entrepreneurship

Standalone Modules

Module 8 - Digitalisation, Software and Cybersecurity



Module 8 focuses on the regulatory framework for medical device software. It provides an overview of the software development lifecycle and the management of software quality. The module additionally covers cybersecurity and the regulation of devices based on artificial intelligence.

Learning objectives

Once you have successfully completed this module, participants understand the regulatory framework for medical device software, cybersecurity and artificial intelligence (AI), the software lifecycle processes, the role of software technologies in the medical device industry and the issues pertaining to their use, and the terminology, principles, application, threats and opportunities of AI and Machine Learning in the medical device field. 

Learning content

Module Digitalisation and Cybersecurity includes the regulatory framework for medical device software, cybersecurity and AI, Software Lifecycle Processes according to IEC 62304 and IEC 82304, disruptive technologies and digitalization, software and cybersecurity in the medical device field, cryptography, Cloud Computing and Software Development for connected devices, and Software Developemt methodology for connected devices. It also involves an understanding for the modern software develop-ment and AI and Machine Learning and big data: impact and approaches.

Start & Duration

2020: 25 October 2021
2021: TBC

The completion of this module takes approximately 8 weeks.




The cost of this standalone module is 3'1500.– SFr.




Module Leaders

Founder and CEO of QUAREGIA GmbH, Founder and CEO of PROREGIA AG

Mathias Eng

Mathias T. Eng is an expert for quality management systems and medical device regulations. In 2019 T. Eng founded QUAREGIA GmbH and in 2020 he founded PROREGIA AG. At QUAREGIA Mathias T. Eng provides quality management- and regulatory affairs services for medical devices, in-vitro diagnostic devices, combination products, medical device software, cybersecurity and artificial intelligence.

System Analyst, Cybersecurity expert, PROREGIA AG

Dr. Larissa Naber