Legislation and Standards Related to Medical Devices (5 cr)
Code: IT00FD40-3001
General information
Enrollment
01.06.2023 - 31.08.2023
Timing
21.08.2023 - 17.12.2023
Number of ECTS credits allocated
5 op
Virtual portion
5 op
Mode of delivery
Distance learning
Unit
School of ICT
Teaching languages
- English
Seats
0 - 30
Degree programmes
- Master's Degree Programme in Information Technology
Teachers
- Mikael Soini
Groups
-
T1623S6-MInformation Technology (MEng): Medical Technology
Objective
After completing this course, the student is familiar with medical device regulation, can identify and evaluate medical device regulation requirements, knows essential standards, guidance documents and methods and is able to utilize them appropriately, and fluently manages on-time communication.
Content
• Medical device regulation in EU: requirements for medical devices and manufacturers
• Risk and quality management
• Medical device intended use, classification, standards, methods and guidance documents
• Practical application of knowledge and skills to a selected medical device or software
Evaluation scale
0-5
Assessment criteria, satisfactory (1)
Student is familiar with medical device regulation. Student is able to identify and describe medical device regulation requirements. Student knows and can use essential standards, guidance documents and methods. Student can communicate and report results.
Assessment criteria, good (3)
Student is properly familiar with medical device regulation. Student is able to identify and evaluate medical device regulation requirements. Student properly knows essential standards, guidance documents and methods and is able to apply them appropriately. The student knows how to communicate and report the results clearly within the given schedule.
Assessment criteria, excellent (5)
Student is excellently familiar with medical device regulation. Student is able to critically and thoroughly identify and evaluate medical device regulation requirements. Student excellently knows essential standards, guidance documents and methods and is able to apply them appropriately and in high-level. The student knows how to communicate and report the results convincingly within the given schedule.
Assessment criteria, approved/failed
Student is familiar with medical device regulation. Student is able to identify and describe medical device regulation requirements. Student knows and can use essential standards, guidance documents and methods. Student can communicate and report results.