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.
Origin M.Sc. Computer Science
Duration,
frequency		 One semester,
unregelmäßig
Person in charge of the module's outline N.N.

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

Translation is missing, sorry. German original:

Die Studierenden

  • können Konzepte der Softwareentwicklung für die Medizin beschreiben und einsetzen,
  • können Querverbindungen zur Informatik aufzeigen,
  • können Denk- und Arbeitsweisen der Regulierungsbehörden an konkreten Fragestellungen, auch an technisch motivierten Problemstellungen, anwenden,
  • haben eine Intuition für die Entwicklung von Software als Medizinprodukt und können diese in präzise Begriffe und formale Begründungen umsetzen,
  • sind in der Lage, über wissenschaftliche Inhalte frei zu sprechen, sowohl vor einem Publikum als auch in einer Diskussion.

Prerequisites

None. Basic knowledge of software engineering is recommended.


Applicability

The module can be attended at FB12 in study program(s)

  • B.Sc. Data Science
  • B.Sc. Computer Science
  • M.Sc. Data Science
  • M.Sc. Computer Science

When studying M.Sc. Computer Science, this module can be attended in the study area Compulsory Elective Modules in Computer Science.

The module can also be used in other study programs (export module).

The module is assigned to Practical Computer Science. Further information on eligibility can be found in the description of the study area.


Recommended Reading

(not specified)



Please note:

This page describes a module according to the latest valid module guide in Winter semester 2025/26. 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
  • Winter 2025/26

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.