Main content

CS 558 — Software as a Medical Device
(dt. Software als Medizinprodukt)

Level, degree of commitment Specialization module, depends on importing study program
Forms of teaching and learning,
workload		 Lecture (2 SWS), recitation class (2 SWS),
180 hours (60 h attendance, 120 h private study)
Credit points,
formal requirements		 6 CP
Course requirement(s): Successful completion of at least 50 percent of the points from the weekly exercises as well as at least 2 presentations of the tasks.
Examination type: Oral examination (individual examination) or written examination
Language,
Grading		 English,
The grading is done with 0 to 15 points according to the examination regulations for the degree program M.Sc. Computer Science.
Subject, Origin Computer Science, M.Sc. Computer Science
Duration,
frequency		 One semester,
unregelmäßig
Person in charge of the module's outline Prof. Dr. Dominik Heider

Contents

  • What is ''medical device software''?
  • Requirements for processes and products
  • Overview of quality management
  • How does the regulatory framework fit with software development processes?
  • Relevant standards
  • Selected topics from quality management: (usability, risk management, configuration management)
  • Approval processes
  • Audits
  • After the release: changes, errors, updates

Qualification Goals

Students

  • Have knowledge and skills of software development for medicine,
  • can recognize cross connections to computer science,
  • can apply ways of thinking and working in regulatory agencies to concrete issues, including technically motivated problems,
  • have an intuition for the development of software as a medical product and are able to translate this into precise terms and formal justifications,
  • are able to speak freely about scientific content, both in front of an audience and in a discussion.

Prerequisites

None. The competences taught in the following module are recommended: Software Engineering. Basic knowledge of software engineering is recommended.


Recommended Reading

(not specified)



Please note:

This page describes a module according to the latest valid module guide in Winter semester 2023/24. Most rules valid for a module are not covered by the examination regulations and can therefore be updated on a semesterly basis. The following versions are available in the online module guide:

  • Winter 2016/17 (no corresponding element)
  • Summer 2018 (no corresponding element)
  • Winter 2018/19 (no corresponding element)
  • Winter 2019/20 (no corresponding element)
  • Winter 2020/21 (no corresponding element)
  • Summer 2021 (no corresponding element)
  • Winter 2021/22 (no corresponding element)
  • Winter 2022/23 (no corresponding element)
  • Winter 2023/24

The module guide contains all modules, independent of the current event offer. Please compare the current course catalogue in Marvin.

The information in this online module guide was created automatically. Legally binding is only the information in the examination regulations (Prüfungsordnung). If you notice any discrepancies or errors, we would be grateful for any advice.