Medical Device product development (5 cr)
Code: 5251003-3003
General information
Enrollment
02.12.2024 - 31.01.2025
Timing
13.01.2025 - 11.05.2025
Number of ECTS credits allocated
5 op
Mode of delivery
Contact teaching
Teaching languages
- Finnish
Degree programmes
Teachers
- Sari Airenne
Groups
-
MKEMIK22
- 13.01.2025 13:00 - 14:00, Lukukauden aloitusinfo, MKEMIK22 (TEAMS)
- 13.01.2025 14:00 - 16:00, Opinnäyteasiaa ja -työpaja, MKEMIK22 (Teams)
- 31.01.2025 09:00 - 11:00, Lääkinnällisen laitteen tuotekehitys 5251003-3003
- 14.02.2025 09:00 - 11:00, Lääkinnällisen laitteen tuotekehitys 5251003-3003
- 14.03.2025 09:00 - 11:00, Lääkinnällisen laitteen tuotekehitys 5251003-3003
- 25.04.2025 09:00 - 11:00, Lääkinnällisen laitteen tuotekehitys 5251003-3003
Objective
After finishing the course the student is capable of:
- Is familiar with the regulation and legislation that guide the development of medical devices
- Knows the standards that are widely used and understands their role in medical device product development
- Knows risk analysis methods and requirements
- Understands the meaning and impacts of quality systems for product development.
Content
- Legistlation and regulation of medical device development
- Product development standards
- Risk management
- Quality system
- Usability
- Software as a medical device
Evaluation scale
H-5