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. With the focus on medical device regulatory affairs, the RAS curriculum provides a deep understanding of the requirements and procedures for FDA and international regulatory submissions, and regulatory compliance activities. In their culminating project, students apply their course learning to a real regulatory project in a medical device company.

The RAS Master's Program requires a total of 33 credits at $750 per credit. Students can complete the RAS Program in two years.

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2013-14 Course Catalog (pdf)
Master of Science in Regulatory Affairs and Services
The first in the country for medical devices

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-643:  Reimbursement and Cost Management for Medical Technology

RAS-690 Regulatory Affairs Culminating Project

Elective Courses:

RAS-641: Health Policy and the Medical Technology Industry

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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