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Medical Device Design and Development (5 cr)

Code: 5051256-3001

General information


Enrollment

09.06.2021 - 30.08.2021

Timing

30.08.2021 - 31.12.2021

Number of ECTS credits allocated

5 op

RDI portion

3 op

Mode of delivery

Contact teaching

Unit

Engineering and Business

Campus

Kupittaa Campus

Teaching languages

  • Finnish

Seats

15 - 30

Degree programmes

  • Degree Programme in Information and Communication Technology
  • Degree Programme in Information and Communications Technology

Teachers

  • Johannes Hautamäki

Groups

  • PTIVIS18H
    PTIVIS18H

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