Quality Systems for Regulated Industries
General
Prefix
RAS
Course Number
633
Course Level
Graduate
Department/Unit(s)
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
MN Goal Course
No
Cultural Diversity
No
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: