MTQ626 - Medical Technology Quality Systems

General

Prefix

MTQ

Course Number

626

Course ID

00150959

Course Level

Graduate

Instruction Mode

Lecture

Description

Application, management responsibilities, and planning concepts of Quality management systems. US and international standard requirements, and current document control processes in the development, manufacture and distribution of medical devices.

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

Apply Quality Systems Management

Outcome

Apply specific US and International standards and regulations

Outcome

Determine Management Responsibility in a Quality System

Outcome

Correctly apply Internal Audit processes and requirements

Outcome

Design and apply Records, Documents and Change Control systems

Outcome

Develop content and implement Quality Sytems Manuals

Outcome

Summarize Corrective and Preventive Action (CAPA) Processes

Course Outline

Course Outline

-

Dependencies

Courses

MTQ626 is a prerequisite for:

Programs

MTQ626 is a completion requirement for: