Quality Systems for Regulated Industries

General

Prefix

RAS

Course Number

633

Course Level

Graduate

College/School

College of Science and Engineering

Description

Training in the content and scope of Quality Systems necessary to be an effective participant/leader in the regulated medical device industry, the evolution of quality system requirements and current perspectives on the interpretation of standards.

Credits

Min

3

Max

3

Repeatable

No

Goals and Diversity

Learning Outcomes

Outcome

Introduce the overarching process and pathway for global medical device clearance/approvals.

Outcome

Examine the purpose of quality systems and standards; explain the history and impact on product and public safety over time as well as the importance of quality products from the perspective of healthcare providers (clinical use as well as product performance).

Outcome

Describe US quality system requirements (QSR)/EU quality management system (QMS) requirements throughout the product lifecycle.

Outcome

Analyze and identify the differences, similarities, and interdependencies between QSR/QMS requirements and standards applicable to support the development, manufacturing and monitoring of healthcare products.

Outcome

Determine the interactions between professionals and regulatory bodies.

Outcome

Interpret and address Quality System inspection questions and observations related to the manufacturer of medical products.

Outcome

Analyze and respond appropriately to regulatory communications and questions with clear and concise technical responses.

Dependencies

Courses

RAS633 is a prerequisite for:

Programs

RAS633 is a completion requirement for: