Intl Regulatory Affairs: European Union, East Europe, Australia & Canada
General
Prefix
RAS
Course Number
627
Course Level
Graduate
Department/Unit(s)
College/School
College of Science and Engineering
Description
International regulatory affairs for medical devices with emphasis on the European Union (EU), Eastern Europe, Australia and Canada Regulatory requirements. Classification, marketing submissions, and pre- and post-market approval requirements. Regulatory strategies for global market introduction and planning for the challenges of global regulation.
Credits
Min
3
Max
3
Repeatable
No
Goals and Diversity
MN Goal Course
No
Cultural Diversity
No
Learning Outcomes
Outcome
Examine basic principles and challenges supporting regulatory systems in specified countries.
Outcome
Identify and interpret the medical device regulations (EU MDR).
Outcome
Create regulatory plan and expand into a global market introduction strategy.
Outcome
Interpret risk-based classification regulations.
Outcome
Describe clinical evaluation process, technical documentation, harmonized standards, and guidance documents that satisfy safety and performance, quality management system and labeling requirements.
Outcome
Determine the conformity assessment pathway and post-market surveillance plan.
Outcome
Manage medical device registration and licensing requirements.
Outcome
Identify CE marking process and analyze global requirements involved in marketing regulated products.
Outcome
Discuss Medical Device Single Audit Program (MDSAP) and personnel training requirements.
Dependencies
Courses
RAS627
is a
prerequisite
for:
Programs
RAS627
is a
completion requirement
for: