Fachhochschule Linz

I give one integrated lecture in Linz (held in English), Applied Software LifeCycle Processes, which covers two semesters. The aim of the lecture is to give the students an introduction into how to write compliant medical software.

During the course, the students are provided a very minimalistic quality management system (a stripped down MedWiki-QM) and are asked to do various tasks directly within the Wiki system.

In teams of three or four they are guided through the development of a small medical device (either standalone software or integrated into a system) alongside with the necessary verification and validation tasks.

The lecture does not strictly follow the EN 62304, but covers most aspects of the standard. Where applicable, links to risk management according to EN ISO 14971 is given.

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