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
Module 8 starts in October each year.
The completion takes approximately 8 weeks.
Credits
3 ECTS
Fee
The cost of this standalone module is 3'150.– SFr.
Reference
03.008
