sitem-insel AG

M8 - Digitalisation, Software and Cybersecurity

Module leaders: Hansjörg Riedwyl, ISS AG
Mathias Eng, QUAREGIA GmbH and PROREGIA AG
Dr. Larissa Naber, PrROREGIA AG



Date and Credits

Start: 25.10.2021

Duration: 8 Weeks

3 ECTS

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

  • To understand the regulatory framework for medical device software, cybersecurity and artificial intelligence (AI)
  • To understand software lifecycle processes
  • To understand the role of software technologies and in the medical device industry and to understand issues pertaining to their use
  • To understand the terminology, principles, application, threats and opportunities of AI & Machine Learning in the medical device field

Learning content

  • The Regulatory framework for medical device software, cybersecurity and AI
  • Software Lifecycle Processes according to IEC 62304 and IEC 82304
  • Disruptive technologies and digitalization
  • Understanding Modern software development
  • Software and cybersecurity in the medical device field
  • Disruptive technologies and digitalization
  • Cryptography
  • Cloud Computing & Software Development for connected devices
  • Software Development methodology for connected devices
  • AI & Machine Learning and big data: impact and approaches