General course aim: after the course the student has gained in-depth knowledge of the development process of artificial organs as a medical product with all its different phases and tasks and has gained in-depth knowledge of the medical/physiological background of the artificial organs covered (heart, lungs, kidneys).|
After the course, the student is able to …
- give an in-depth description of the process phases of the development process
- describe the difference between a project and a product risk analysis
- independently analyze the requirements for an artificial organ such as lung, kidney, or heart based on physiological, anatomical, surgical, and technical considerations and document them in a way relevant for CE-approval
- generate a test plan for verification and validation purposes
The course will give insight on medical devices for the support or replacement of the internal organs heart, lungs, and kidneys, incorporate the interaction between blood and the medical device, fundamentals of hemodynamics and the anatomy and physiology of the natural organ in comparison to the artificial organ.|
The development process of artificial organs as medical devices will be the leading topic throughout the course, covering the user and design requirement specifications, risk analysis, design and usability, verification and validation testing, and documentation relevant for CE approval.
Due to the uncertainties of future corona restrictions the assignments will be systematic literature researches on various topics the students can choose from a given list of topics.