Product Development ProjectLaajuus (5 cr)

Objectives

The student
- knows how to work in a multidisciplinary product development project team
- knows the key terminology and methods of project management and product development
- knows the standards and regulatory requirements for health technology product development and its documentation
- knows the product development process and project phases for medical devices and medical device software
- knows how to take into account user needs and requirements in product development project

Content

Projects and project management
Product development process and product development project
Human- and user-centered design, user needs and product requirements
Health technology product development guided by regulations and standards
Medical device software life cycle processes
Medical device product development project, its phases and documentation

Assessment criteria, satisfactory (1-2)

The student
- knows the key terminology and methods of project management and product development
- is able to work in a multidisciplinary product development project team
- knows the phases of product development process and project of medical devices and software
- is able to identify user needs and product requirements in product development project

Assessment criteria, good (3-4)

The student
- can apply the key terminology and methods of project management and product development
- is able to work well in a multidisciplinary product development project team
- knows the phases of product development process and project of medical devices and software, and the documentation requirements
- is able to apply methods to identify user needs and product requirements in product development project

Assessment criteria, excellent (5)

The student
- broadly understands the key terminology and methods of project management and product development
- is able to work excellently in a multidisciplinary product development project team
- is able to apply the phases of product development and project of medical devices and software, and the documentation requirements
- is able to apply methods to identify and fulfill user needs and requirements in product development project