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Quality- and Riskmanagement for Medical Devices (MGST-B-5-R-QRM-ILV)
Department
- Bachelor's program Medical, Health and Sports Engineering
Course unit code
- MGST-B-5-R-QRM-ILV
Level of course unit
- Bachelor
Year of study
- Fall 2024
Semester when the course unit is delivered
- 5
Number of ECTS credits allocated
- 2.0
Name of lecturer(s)
- Rubisoier Daniel, BSc MSc
Learning outcomes of the course unit
- The students
- Understand the impact of regulations on manufacturers, notified bodies and users of medical devices.
- Are familiar with risk-based approaches.
Recommended optional program components
- keine
Course contents
- Quality management system (QMS) & Risk management (RM)
General overview of QMS & RM
Overview ISO 13485 (Medical devices – Quality management systems – Requirements for regulatory purposes )
Overview ISO 14971 (Medical devices – Application of risk management to medical devices)
Recommended or required reading
- - ISO 13485:2016 Medical devices — Quality management sys-tems — Requirements for regulatory purposes
- ISO 14971:2019 Medical devices — Application of risk man-agement to medical devices
Planned learning activities and teaching methods
- In der Lehrveranstaltung werden verschiedenste Lehr- und Lernformen (Vortrag, Einzel- und Gruppenarbeit, Diskussion, etc.) auf interaktive Art und Weise verknüpft.
Assessment methods and criteria
- Homework 1 (10%) + Homework 2 (10%) + Exam (80%) (Multiple Choice Test)
Language of instruction
- English
Work placement(s)
- keine