Laajuus (2 cr)
Code: TE00BY68
Credits
2 op
Objective
After the course students:
- Can describe the definitions of medical devices
- Can categorize the medical devices
- Can recognize the essential ISO standards and regulations regarding to medical devices in European Union
- Know the principles and value of regulation regarding medical devices
- Be familiar with the basic principles of ISO 13485:2016 standard
- Apply ISO 13485:2016 standard in practically
Content
- Principles and classification of medical devices (which products are medical devices?)
- the classification of medical devices in European Union (EU regulation)
- CE marked product
- ISO 13485:2016 standard