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Medical Device product development (5 cr)

Code: 5251003-3003

General information


Enrollment

02.12.2024 - 31.01.2025

Timing

13.01.2025 - 11.05.2025

Number of ECTS credits allocated

5 op

Mode of delivery

Contact teaching

Teaching languages

  • Finnish

Degree programmes

Teachers

  • Sari Airenne

Groups

  • MKEMIK22
  • 13.01.2025 13:00 - 14:00, Lukukauden aloitusinfo, MKEMIK22 (TEAMS)
  • 13.01.2025 14:00 - 16:00, Opinnäyteasiaa ja -työpaja, MKEMIK22 (Teams)
  • 31.01.2025 09:00 - 11:00, Lääkinnällisen laitteen tuotekehitys 5251003-3003
  • 14.02.2025 09:00 - 11:00, Lääkinnällisen laitteen tuotekehitys 5251003-3003
  • 14.03.2025 09:00 - 11:00, Lääkinnällisen laitteen tuotekehitys 5251003-3003
  • 25.04.2025 09:00 - 11:00, Lääkinnällisen laitteen tuotekehitys 5251003-3003

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