Lainsäädäntö ja standardit (5 cr)
Code: IT00EM64-3002
General information
Enrollment
01.06.2022 - 29.08.2022
Timing
30.08.2022 - 14.10.2022
Number of ECTS credits allocated
5 op
Mode of delivery
Contact teaching
Unit
ICT ja tuotantotalous
Campus
Myllypurontie 1
Teaching languages
- English
Seats
0 - 25
Degree programmes
- Master's Degree Programme in Information Technology
Teachers
- Sakari Lukkarinen
- Mikael Soini
Teacher in charge
Mikael Soini
Groups
-
T1622S6-MInformation Technology (MEng): Medical Technology
Objective
After completing this course student is familiar with medical device regulation, can identify and evaluate medical device regulation requirements, knows essential standards 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
• Essential standards
• Methods for defining intended use and risk class, and risk management
• Defining intended use and risk class, and implementing risk management for selected medical device
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 and methods. Student can communicate and report results on time.
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 and methods and is able to apply them appropriately. Student can explicitly communicate and report results on time.
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 and methods and is able to apply them appropriately and in high-level. Student can convincingly communicate and report results on time.