Medical Device Quality and Regulatory Fundamentals
General
Prefix
MTQ
Course Number
620
Course Level
Graduate
Department/Unit(s)
College/School
College of Science and Engineering
Description
Medical device and quality regulatory requirements for both FDA and international regulations and standards.
Credits
Min
3
Max
3
Repeatable
No
Goals and Diversity
MN Goal Course
No
Cultural Diversity
No
Learning Outcomes
Outcome
Explain the history and purpose of medical technology regulations and standards.
Outcome
Apply the basic quality concepts, tools, and methods used to meet medical device requirements.
Outcome
Analyze and identify the differences, similarities, and interdependencies between regulations and standards applicable to medical devices.
Outcome
Determine the interactions between quality professionals and regulatory bodies.
Outcome
Formulate how compliance provides business value.
Dependencies
Courses
MTQ620
is a
prerequisite
for:
Programs
MTQ620
is a
completion requirement
for: