eHealth

Development of Medical Software as a Medical Device

Integrated course, 5.00 ECTS

 

Course content

  • Regulatory Requirements (Medical Device Regulation, ISO 13485, IEC 62304, IEC 62366, ISO 14971…)
  • Software Life-Cycle
  • Development roles
  • Technical documentation
  • Change management
  • Configuration management
  • Vigilance
  • Approval process and Audit
  • Software Requirements and Requirements Analysis
  • Usability
  • Risk management
  • Clinical Evaluation Report and Clinical Evaluation

Learning outcomes

Goals:

  • Overview of the processes, normative and legal aspects as well as presentation of essential tools in the development of software as a medical product.
  • Development of a basic understanding of the product life cycle of software as a medical device and the stakeholders involved.
Non-goals:
  • Development of programming skills and software design (skills are required).
  • Planning of clinical studies according to AMG or MPG that are required to prove the effectiveness of medical products.
After the lecture you can:
  • ... describe the product life cycle of software as a medical device
  • ... describe the necessary roles in the development
  • ... understand and define the necessary "essential requirements" of software as a medical device
  • ... plan the necessary "technical documentation" for a software release
  • ... create a "clinical evaluation report" and define the basis for a "clinical evaluation"
  • ... derive the connection between software requirements and usability and risk management

Recommended or required reading and other learning resources / tools

  • Software als Medizinprodukt Entwicklung und Zulassung von Software in der Medizintechnik, Springer 2019, Mark Hastenteufel, Sina Renaud
  • Basiswissen Medizinische Software: Aus- und Weiterbildung zum Certified Professional for Medical Software, Christian Johner, Matthias Hölzer-Klüpfel, Sven Wittorf, dpunkt.verlag, 2015

Mode of delivery

5 ECTS ILV

Prerequisites and co-requisites

Software development, quality management, technical documentation

Assessment methods and criteria

VO: final exam; UE: course-immanent examination character

Total points 100
    Final exam 34
    Group exercises 33 (Intended Use & Classification / Requirements Analysis & Specifications = 9, Usability / Risk Management = 8
    clinical evaluation = 16)
    Presentation 33

Each partial evaluation must be concluded positively
Min. 60% positive; 61-70 (sufficient), 71-80 (satisfactory), 81-90 (good), 91-100 (very good)