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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

01.06.2024 - 09.09.2024

Timing

02.09.2024 - 15.12.2024

Number of ECTS credits allocated

5 op

Mode of delivery

Contact teaching

Unit

Engineering and Business

Campus

Kupittaa Campus

Teaching languages
  • Finnish
Seats

0 - 35

Teachers
  • Pauliina Tryykilä
Groups
  • PTIVIS21H
    Terveysteknologia

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

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
  • PTIVIS20H
    Terveysteknologia

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
  • PTIVIS19H
    Terveysteknologia

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