Medical Device Regulatory Path (5 cr)

Objective

After completing the course, the student understands the issues related to the life cycle of a medical device, starting from the idea and ending with decommissioning, is able to utilize various standards and methods to meet the requirements, and is able to apply the knowledge and skills learned in specifying and designing a medical device.

Content

Stages of a medical device life cycle
Key regulatory requirements for the medical device manufacturer
Medical, functional and user requirements
Standards and guidelines
Specification and design of a medical device

Evaluation scale

0-5

Assessment criteria, satisfactory (1)

Student has achieved the course objectives. Student will be able to identify, define and use the course subject area’s concepts and models. Student understands the criteria and principles of the expertise development.

Assessment criteria, good (3)

Student has achieved the course objectives well, even though the knowledge and skills need improvement on some areas. Student is able to define the course concepts and models and is able to justify the analysis. Student is able to apply his/her knowledge in study and work situations. Student understands the importance of expertise in the field of information and communication technology and is able to analyze his/her own expertise.

Assessment criteria, excellent (5)

Student has achieved the objectives of the course with excellent marks. Student masters commendably the course subject area’s concepts and models. Student is able to make justified and fluent analysis and to present concrete development measures. Student is well prepared to apply his/her knowledge in study and work situations. Student is able to analyze expertise in the information and communication technology sector and the development of his/her own expertise.

Assessment criteria, approved/failed

Student has achieved the course objectives. Student will be able to identify, define and use the course subject area’s concepts and models. Student understands the criteria and principles of the expertise development.