Medical Device product developmentLaajuus (5 cr)
Code: 5251003
Credits
5 op
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
Enrollment
02.05.2023 - 06.09.2023
Timing
23.08.2023 - 30.11.2023
Number of ECTS credits allocated
5 op
Mode of delivery
Contact teaching
Unit
Engineering and Business
Teaching languages
- Finnish
Degree programmes
Teachers
- Sari Airenne
Teacher in charge
Sari Airenne
Groups
-
MKEMIK21
-
MKEMIS20
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
Enrollment
01.06.2022 - 09.11.2022
Timing
29.08.2022 - 16.12.2022
Number of ECTS credits allocated
5 op
Mode of delivery
Contact teaching
Unit
Engineering and Business
Teaching languages
- Finnish
Degree programmes
Teachers
- Sari Airenne
Teacher in charge
Sari Airenne
Groups
-
MKEMIS19
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