Study Guide

Objective

After completing this course student is familiar with medical device business environment, can identify and understand different phases of medical device life cycle, knows medical device life cycle management related tools and standards and is able to utilize them appropriately, and fluently manages on-time communication.

Content

• Medical device business environment
• Medical device from idea to post-market
• Tools and standards related to medical device life cycle management
• Carrying out a feasibility study for selected medical device

Assessment criteria, satisfactory (1)

Student is familiar with medical device business environment. Student is able to identify and describe different phases of medical device life cycle. Student knows and can use medical device life cycle management related tools and standards. Student can communicate and report results on time.

Assessment criteria, good (3)

Student is properly familiar with medical device business environment. Student is able to identify and understand different phases of medical device life cycle. Student properly knows medical device life cycle management related tools and standards 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 business environment. Student is able to critically and thoroughly identify and understand different phases of medical device life cycle. Student excellently knows medical device life cycle management related tools and standards and is able to apply them appropriately and in high-level. Student can convincingly communicate and report results on time.