Development of Medical Software as a Medical Device
Integrated course, 5.00 ECTS
- Regulatory Requirements (Medical Device Regulation, ISO 13485, IEC 62304, IEC 62366, ISO 14971…)
- Software Life-Cycle
- Development roles
- Technical documentation
- Change management
- Configuration management
- Approval process and Audit
- Software Requirements and Requirements Analysis
- Risk management
- Clinical Evaluation Report and Clinical Evaluation
- 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.
- 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.
- ... 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)
Each partial evaluation must be concluded positively
Min. 60% positive; 61-70 (sufficient), 71-80 (satisfactory), 81-90 (good), 91-100 (very good)