RAS Program Curriculum
The RAS curriculum has been developed under the guidance and support of our expert RAS faculty and the industry Advisory Board. Electives were added in 2010 to better serve individual student needs. Courses are also reviewed annually to incorporate new and changing regulatory requirements.
The RAS curriculum includes eight core cores, two electives and a culminating project for a total of 33 credits. Students can complete the RAS Masters Program in two years. Click here to access the Full Course Catalog.
To review the course descriptions and learning objectives for each course, click on the course titles.
RAS Course catalog
Core Courses:
RAS-621: Legal Basis for Medical Device Product Regulation
RAS-623: Regulatory Routes to Market: 510(k)s
RAS-625: Regulatory Routes to Market: PMAs
RAS-627: International Regulatory Affairs: European Union, Eastern Europe, Australia and Canada
RAS-631: IDE Regulations and Clinical Trial Design
RAS-633: Quality Systems for Regulated Industry
RAS-635: Regulatory Affairs Compliance
RAS-641: Health Policy and the Medical Technology Industry
OR
RAS-643: Reimbursement and Cost Management for Medical Technology
RAS-690 Regulatory Affairs Culminating Project
Elective Courses:
RAS-651: Regulation of Combination Products
RAS-653: Ethics in Regulatory Affairs and Clinical Trials
RAS-655: International Regulatory Affairs: Japan, Other Asia, Latin America and Middle East
Other electives may be selected with the approval of the RAS Program Director.
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