Medical Device Design and DevelopmentLaajuus (5 cr)
Code: 5051256
Credits
5 op
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
Enrollment
05.06.2023 - 30.08.2023
Timing
31.08.2023 - 31.12.2023
Number of ECTS credits allocated
5 op
Mode of delivery
Contact teaching
Unit
Engineering and Business
Campus
Kupittaa Campus
Teaching languages
- Finnish
Seats
20 - 40
Degree programmes
- Degree Programme in Information and Communication Technology
Teachers
- Pauliina Tryykilä
Teacher in charge
Pauliina Tryykilä
Groups
-
PTIVIS20HTerveysteknologia
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
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