Medical Device Design and Development (5 cr)
Code: 5051256-3002
General information
Enrollment
13.06.2022 - 11.09.2022
Timing
29.08.2022 - 22.12.2022
Number of ECTS credits allocated
5 op
Mode of delivery
Contact teaching
Unit
Engineering and Business
Campus
Kupittaa Campus
Teaching languages
- Finnish
Degree programmes
- Degree Programme in Information and Communication Technology
- Degree Programme in Information and Communications Technology
Teachers
- Johannes Hautamäki
Teacher in charge
Johannes Hautamäki
Groups
-
PTIVIS19HTerveysteknologia
Objective
After completing the course the student:
- is familiar with legislation and regulatory bodies that play a key role in product development of medical devices
- is able to designate commonly used standards for product development in medical devices and understand their importance in product development
- understands the purpose and requirements for risk management process
- understands the purpose and impact of the quality management system for product development
Content
- Legislation and regulations on medical device product development
- Product development standards
- Risk management
- Quality system
- Software as a medical device
Evaluation scale
H-5