Opinto-opas

Objective

After completing the course, the student applies team and project work skills, applies the knowledge and skills learned in this study module in the project work focusing on medical device development, understands authorities controlling product development and stakeholders’ roles and perspectives, and understands and uses quality and risk management basics in the project.

Content

• Practice-oriented project
• Medical devices
• Medical device related statutes, decrees, directives and regulating authorities
• Quality control and related standards
• Risk assessment

Evaluation scale

0-5

Assessment criteria, satisfactory (1)

Student uses team and project work skills, is part of a team in the project, and recognizes authority specifications and quality and risk management basics in the project.

Assessment criteria, good (3)

Student applies team and project work skills, applies the knowledge and skills learned in this study module in the project, and understands authority specifications and quality and risk management basics in the project.

Assessment criteria, excellent (5)

Student applies and develops team and project work skills, applies and develops the knowledge and skills learned in this study module in the project in advanced manner, and understands and utilizes authority specifications and quality and risk management basics in the project.

Assessment criteria, approved/failed

Student uses team and project work skills, is part of a team in the project, and recognizes authority specifications and quality and risk management basics in the project.