BMT-62237 Introduction to Quality and Regulation for Medical Product Development, 5 cr

Implementation BMT-62237 2019-01

Description

On this course we will study the life cycle and main steps of a biomedical device product research and development process. Student can understand the main principles and challenges of medical device development. Student can recognize main standards and regulations concerning medical devices and can explain the main parts of the quality systems for the medical devices. Student can explain main principles and most typical tests for electrical and biological safety as well as mechanical and biomechanical testing.

Lessons

Assessment scale

Numerical evaluation scale (0-5)

Requirements

Accepted exercise work (three mandatory exercises) and final exam.