Non-Degree Student Information

Medical Device Educational Opportunities

Individual RAS courses are excellent training and professional development resources for those in the medical device industry and those interested in getting into the industry.

MSRAS course catalog

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

Industry scrutiny by FDA and international regulatory bodies is increasing. Regulatory compliance and timely market approvals are not just the responsibility of regulatory affairs. Those who contribute to regulatory submissions or are involved in compliance activities would benefit from an understanding of the regulatory requirements and environment and how it affects their responsibilities. 
The broad based RAS curriculum is designed to train regulatory affairs professionals. Individual RAS courses can also be of applicable for R&D, manufacturing engineers, quality, clinical, marketing and other medical device professionals. The following courses are foundational and examples of courses with broad applicability in a medical device organization. 

  • RAS-621: Legal Basis for Medical Product Regulation
  • RAS-633: Quality Systems for the Regulated Industry
  • RAS-635: Regulatory Affairs Compliance

For a complete listing of RAS courses including course descriptions, learning objectives and listings of who would benefit click on the RAS Course Catalog above.
From a training and professional development stand point, RAS courses are far superior to on the job training.  RAS courses are also more comprehensive, more convenient and more economical than a seminar on a similar topic in Washington D. C. or other location. 

  • Comprehensive: A three credit RAS course involves 36 instructional hours versus 12 – 20 hours in a typical conference.
  • Structured Learning Environment:  RAS courses are spread over 10 – 12 weeks with practical and real word medical device assignments and projects. This provides a better work environment than a seminar can provide.
  • Convenient: Courses are offered in Maple Grove, MN at the St. Cloud State University Twin Cities Graduate Center. Classes are held on Saturday mornings and weekday evenings and do not interfere with the work day. Seminars typically take 2 – 3 days away from work.
  • Economical: Tuition for RAS courses is $750 per credit or $2250 for a 3 credit course. Registration cost for a 2 – 3 day seminar is typically $1400 – 1900. Factoring in airfare, lodging and meals the total cost is typically in the $2500 – 4000 range. 

Registration for individual RAS courses requires an undergraduate degree. Prior industry experience may also be needed depending on the specific course and individual’s responsibilities and learning objectives. Individual RAS courses are open to students outside the Twin Cities area via Adobe Connect.

The following 2014-15 RAS courses are open to independent students subject to prerequisites listed in the RAS Course Catalog.

Fall (last day to register is August 29, 2014)

  • RAS-621 Legal Basis for Medical Product Regulation
  • RAS-625 Regulatory Routes to Market: PMAs
  • RAS-633 Quality Systems for Regulated Industry
  • RAS-653 Ethics in Regulatory Affairs and Clinical Trials
  • RAS-655 International Regulatory Affairs: Japan, Other Asia, Latin America Middle East

Spring (last day to register is January 2, 2015)

  • RAS-623 Regulatory Routes to Market: 510(k)s
  • RAS-631 IDE Regulations and Clinical Trial Design
  • RAS-635 Regulatory Affairs Compliance
  • RAS-651 Regulation of Combination Products

Summer (last day to register is April 27, 2015)

  • RAS-627 International Regulatory Affairs: European Union, Eastern Europe, Australia, Canada
  • RAS-643 Reimbursement and Cost Management for Medical Technology

To apply for individual RAS courses, complete the Special Student Registration Form at the following:

The completed registration form should be submitted to:
School of Graduate Studies
St. Cloud State University
121 Administrative Services
720 Fourth Avenue South
St. Cloud, MN 56301-4498
E- mail: Graduatestudies@stcloudstate.edu

For more information about the RAS Program or individual courses, e-mail ras@stcloudstate.edu.

 

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