Medical Devices and Environments of Use (5 ECTS)

Objective

After completing this course student is familiar with medical devices, can identify, evaluate and justify special characteristics related to medical device clinical context of use, is able to perform requirements specification and can utilize it appropriately, and fluently manages on-time communication.

Content

• Medical devices including physical devices, software and artificial intelligence
• Clinical environments, users, workflow and care guidelines
• Methods for defining clinical requirements
• Specifying clinical requirements for selected medical device

Evaluation scale

0-5

Assessment criteria, satisfactory (1)

Student is familiar with medical devices. Student is able to identify and describe the special characteristics related to medical device clinical context of use. Student knows and can use requirements specification. Student can communicate and report results on time.

Assessment criteria, good (3)

Student is properly familiar with medical devices. Student is able to identify, evaluate and justify the special characteristics related to medical device clinical context of use. Student properly knows requirements specification and is able to apply it appropriately. Student can explicitly communicate and report results on time.

Assessment criteria, excellent (5)

Student is excellently familiar with medical devices. Student is able to critically and thoroughly identify, evaluate and justify the special characteristics related to medical device clinical context of use. Student excellently knows requirements specification and is able to apply it appropriately and in high-level. Student can convincingly communicate and report results on time.