MTQ620 - Medical Device Quality and Regulatory Fundamentals

General

Prefix

MTQ

Course Number

620

Course ID

00150957

Course Level

Graduate

Instruction Mode

Lecture

Description

Medical device and quality regulatory requirements for both FDA and international regulations and standards.

Cross Listed Courses

Prerequisites

No Requisites

Credits

Min

3

Max

3

Repeatable

No

Goals and Diversity

MN Goal Course

No

MN Goal Designation(s)

-

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.

Course Outline

Course Outline

-

Dependencies

Courses

MTQ620 is a prerequisite for:

Programs

MTQ620 is a completion requirement for: