Skip to main content

Medical Device Design and Development (5 cr)

Code: 5051256-3002

General information


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