Regulatory Affairs and Services Graduate Program (M.S. RAS)

Offered through the Academic Center for Regulatory Affairs and Services
College of Science and Engineering, St. Cloud State University
145 Wick Science Building
Phone: 320.308.2192
Fax: 320.308.5124
Email: COSE@stcloudstate.edu
Web site: http://www.stcloudstate.edu/ras/home.asp

Director/Graduate Coordinator: Charles “Chuck” Swanson http://www.stcloudstate.edu/ras/about.asp
Graduate Faculty: http://www.stcloudstate.edu/ras/faculty.asp

The Master of Science in Regulatory Affairs and Services program (M.S. RAS) focuses on the specific educational and career development needs of employees responsible for managing the required regulatory approval processes in the medical device industry. The intent of the program is to prepare students to take leadership roles within the regulatory departments of medical device organizations.

The Profession

The regulatory affairs professional is critical to making safe and effective medical products available to patients worldwide. These professionals ensure compliance to state, federal and international medical device regulations for safety and efficacy. In successful medical device companies, regulatory professionals are involved in all stages of the commercialization process, from initial business planning to design, development, verification, pre-clinical, clinical, manufacturing, packaging, labeling, marketing and post-market surveillance.

The regulatory profession requires versatile individuals with excellent communications skills and a broad knowledge of the following: science and engineering; state, federal and international regulations; and planning and risk management. Increasingly, the success or failure of medical device businesses depends on regulatory affairs, clinical and reimbursement strategies and implementation. As a result, regulatory professionals are taking leadership roles within medical device organizations, and the demand for well-trained and skilled regulatory professionals is growing significantly.

Program Overview

The M.S. RAS provides the means to develop the essential understanding and competencies to work in the regulatory affairs of medical device manufacturers or consulting organizations. It provides experience and relevant training in three broad areas of regulatory affairs and services:

Regulatory affairs
Clinical trials and quality systems
Health economics and reimbursement

Admission Requirements Specific to the Program

An undergraduate degree in engineering, biochemistry, biostatistics, public health, nursing or other appropriate and relevant areas is recommended as a basis for successful completion of the M.S. RAS degree.

Note: The director and selected instructors from the Academic Center for Regulatory Affairs and Services will review applications to ensure each candidate’s qualifications.

Length of Program – Measured by Semesters

Part-time student: six semesters over two years.

Program location and time

The program is offered at North Hennepin Community College located in Brooklyn Park, Minn. For map/location, go online to: http://www.nhcc.edu/About_North_Hennepin/Visit_North_Hennepin/directions.cfm

Computer lab, classrooms, and breakout areas are available for this program.
Students will have full access to electronic resources via a SCSU HuskyNet account, and instruction will be provided by course management software, currently D2L.

Tuition: http://www.stcloudstate.edu/ras/apply.asp

To Apply

Visit the School of Graduate Studies Web site: http://www.stcloudstate.edu/graduatestudies/

The following Web sites provide admission requirements and a checklist for graduate admissions: http://bulletin.stcloudstate.edu/gb/admission/admission.asp#admintest

School of Graduate Studies
Telephone: 320.308.2113
Toll free: 1.800.369.4260
E-mail: graduatestudies@stcloudstate.edu

Master of Science in Regulatory Affairs and Services - 33 credits

Regulatory Affairs

RAS 621. Legal Basis for Medical Device Product Regulation, 3 credits
RAS 623. Investigational Medical Device Regulations, Standards, and Guidelines, 3 credits
RAS 625. Regulatory Submission/Application Requirements for Medical Devices: Routes to Market, 3 credits
RAS 627. International Regulatory Affairs: European Union, Canada, Japan, and Australia, 3 credits

Clinical Trials and Quality Systems

RAS 631. Clinical Study Design, Implementation, and Analysis, 3 credits
RAS 633. Quality Systems for Regulated Industries, 3 credits
RAS 635. Regulatory Affairs Compliance, 3 credits

Health Economics

RAS 641. Health Policy and the Medical Technology Industry, 3 credits
RAS 643. Cost Management of Regulated Health Care Technology, 3 credits
RAS 645. Reimbursement for Medical Technology, 3 credits

Culminating Experience

RAS 690. Regulatory Affairs Culminating Project, 3 credits
This course may be taken over one to three semesters, for a total of three credits. It is required for degree completion.

Course descriptions

RAS 621. Legal Basis for Medical Device Product Regulation
Upon completion of this course, the students will know the objectives and structure of the U.S. Food and Drug Administration, the key regulations associated with medical devices, and the resources available from the FDA to aid in compliance with those regulations. 3 credits

RAS 623. Investigational Medical Device Regulations, Standards & Guidelines
Pertinent ethical, industrial and federal standards and guidelines governing the implementation of medical experiments will be discussed.Specific topics to be addressed include investigational device exemptions, humanitarian use of medical devices, and emergency use of unapproved medical products. 3 credits

RAS 625. Regulatory Submission/Application Requirements for Medical Devices: Routes to Market
Reviews the laws and federal regulations applicable to medical devices in the United States. The medical device classification process will be discussed. 3 credits. Prerequisite: RAS 621.

RAS 627. International Regulatory Affairs: European Union (EU), Canada, Japan, and Australia
Reviews the authorization procedures that are applicable to medical devices scheduled to be marketed in the following international markets: European Union (EU), Canada, Japan, and Australia. The routes to market will be outlined. 3 credits. Prerequisite: RAS 621.

RAS 631. Clinical Study Design, Implementation, and Analysis
Presents the epidemiological and biostatistical principles underlying clinical research of medical devices.The most common study designs used to evaluate medical devices are presented. Prior course in introductory statistics or biostatistics is desirable. 3 credits

RAS 633. Quality Systems for Regulated Industries
Training in the content and scope of quality systems is necessary to be an effective participant/leader in the regulated medical device industry. This training includes the evolution of quality system requirements and current perspectives on the interpretation of standards. 3 credits

RAS 635. Regulatory Affairs Compliance
Students will know the regulations associated with device product listing, facility registration, and product complaint management, and will become aware of other considerations associated with compliance, such as liability, root cause analyses, effective communication, and ethical considerations. 3 credits. Prerequisite: RAS 633.

RAS 641. Health Policy and the Medical Technology Industry
Students will gain a historical perspective of the role of health policy in the development and diffusion of medical technology. Policy issues will be framed in the context of promoting versus inhibiting technology development and diffusion. A major portion of this class is devoted to analysis and critique of current and proposed health policies as they affect the medical technology industry. 3 credits

RAS 643. Cost Management of Regulated Health Care Technology
Upon completion of the course, students will be able to describe the four basic types of economic evaluations and their intrinsic components as well as the modifications required based upon the perspective of the evaluation. They will also be able to critically appraise a published economic analysis of a medical technology. 3 credits. Prerequisite: RAS 641.

RAS 645. Reimbursement for Medical Technology
This is an overview of requirements for reimbursement for medical devices. Students will understand the relationship between the three components of reimbursement: coverage, coding and payment. Students will be able to state the basic components required to assess reimbursement for a new technology and be able to draft a preliminary strategy for gaining reimbursement. 3 credits. Prerequisite RAS 631.

RAS 690. Regulatory Affairs Culminating Project
The culminating experience consists of a research project, starred paper and seminar. Students will develop, carry out and report in written and oral format on an individual research project related to the content of the program courses. The project requires approval of the instructor. Students may take this course over one to three semesters, for a total of three credits. Required for degree.

If you have further questions, please contact the College of Science and Engineering at 320.308.2192 or COSE@stcloudstate.edu

	A-Z Index \| News \| Library \| Technology \| Support St. Cloud State \| St. Cloud State University Home Admissions Academics Student Life About SCSU Athletics Alumni & Friends Regulatory Affairs and Services Graduate Program (M.S. RAS) Offered through the Academic Center for Regulatory Affairs and Services College of Science and Engineering, St. Cloud State University 145 Wick Science Building Phone: 320.308.2192 Fax: 320.308.5124 Email: COSE@stcloudstate.edu Web site: http://www.stcloudstate.edu/ras/home.asp Director/Graduate Coordinator: Charles “Chuck” Swanson http://www.stcloudstate.edu/ras/about.asp Graduate Faculty: http://www.stcloudstate.edu/ras/faculty.asp The Master of Science in Regulatory Affairs and Services program (M.S. RAS) focuses on the specific educational and career development needs of employees responsible for managing the required regulatory approval processes in the medical device industry. The intent of the program is to prepare students to take leadership roles within the regulatory departments of medical device organizations. The Profession The regulatory affairs professional is critical to making safe and effective medical products available to patients worldwide. These professionals ensure compliance to state, federal and international medical device regulations for safety and efficacy. In successful medical device companies, regulatory professionals are involved in all stages of the commercialization process, from initial business planning to design, development, verification, pre-clinical, clinical, manufacturing, packaging, labeling, marketing and post-market surveillance. The regulatory profession requires versatile individuals with excellent communications skills and a broad knowledge of the following: science and engineering; state, federal and international regulations; and planning and risk management. Increasingly, the success or failure of medical device businesses depends on regulatory affairs, clinical and reimbursement strategies and implementation. As a result, regulatory professionals are taking leadership roles within medical device organizations, and the demand for well-trained and skilled regulatory professionals is growing significantly. Program Overview The M.S. RAS provides the means to develop the essential understanding and competencies to work in the regulatory affairs of medical device manufacturers or consulting organizations. It provides experience and relevant training in three broad areas of regulatory affairs and services: Regulatory affairs Clinical trials and quality systems Health economics and reimbursement Admission Requirements Specific to the Program An undergraduate degree in engineering, biochemistry, biostatistics, public health, nursing or other appropriate and relevant areas is recommended as a basis for successful completion of the M.S. RAS degree. Note: The director and selected instructors from the Academic Center for Regulatory Affairs and Services will review applications to ensure each candidate’s qualifications. Length of Program – Measured by Semesters Part-time student: six semesters over two years. Program location and time The program is offered at North Hennepin Community College located in Brooklyn Park, Minn. For map/location, go online to: http://www.nhcc.edu/About_North_Hennepin/Visit_North_Hennepin/directions.cfm Computer lab, classrooms, and breakout areas are available for this program. Students will have full access to electronic resources via a SCSU HuskyNet account, and instruction will be provided by course management software, currently D2L. Tuition: http://www.stcloudstate.edu/ras/apply.asp To Apply Visit the School of Graduate Studies Web site: http://www.stcloudstate.edu/graduatestudies/ The following Web sites provide admission requirements and a checklist for graduate admissions: http://bulletin.stcloudstate.edu/gb/admission/admission.asp#admintest School of Graduate Studies Telephone: 320.308.2113 Toll free: 1.800.369.4260 E-mail: graduatestudies@stcloudstate.edu Master of Science in Regulatory Affairs and Services - 33 credits Regulatory Affairs RAS 621. Legal Basis for Medical Device Product Regulation, 3 credits RAS 623. Investigational Medical Device Regulations, Standards, and Guidelines, 3 credits RAS 625. Regulatory Submission/Application Requirements for Medical Devices: Routes to Market, 3 credits RAS 627. International Regulatory Affairs: European Union, Canada, Japan, and Australia, 3 credits Clinical Trials and Quality Systems RAS 631. Clinical Study Design, Implementation, and Analysis, 3 credits RAS 633. Quality Systems for Regulated Industries, 3 credits RAS 635. Regulatory Affairs Compliance, 3 credits Health Economics RAS 641. Health Policy and the Medical Technology Industry, 3 credits RAS 643. Cost Management of Regulated Health Care Technology, 3 credits RAS 645. Reimbursement for Medical Technology, 3 credits Culminating Experience RAS 690. Regulatory Affairs Culminating Project, 3 credits This course may be taken over one to three semesters, for a total of three credits. It is required for degree completion. Course descriptions RAS 621. Legal Basis for Medical Device Product Regulation Upon completion of this course, the students will know the objectives and structure of the U.S. Food and Drug Administration, the key regulations associated with medical devices, and the resources available from the FDA to aid in compliance with those regulations. 3 credits RAS 623. Investigational Medical Device Regulations, Standards & Guidelines Pertinent ethical, industrial and federal standards and guidelines governing the implementation of medical experiments will be discussed.Specific topics to be addressed include investigational device exemptions, humanitarian use of medical devices, and emergency use of unapproved medical products. 3 credits RAS 625. Regulatory Submission/Application Requirements for Medical Devices: Routes to Market Reviews the laws and federal regulations applicable to medical devices in the United States. The medical device classification process will be discussed. 3 credits. Prerequisite: RAS 621. RAS 627. International Regulatory Affairs: European Union (EU), Canada, Japan, and Australia Reviews the authorization procedures that are applicable to medical devices scheduled to be marketed in the following international markets: European Union (EU), Canada, Japan, and Australia. The routes to market will be outlined. 3 credits. Prerequisite: RAS 621. RAS 631. Clinical Study Design, Implementation, and Analysis Presents the epidemiological and biostatistical principles underlying clinical research of medical devices.The most common study designs used to evaluate medical devices are presented. Prior course in introductory statistics or biostatistics is desirable. 3 credits RAS 633. Quality Systems for Regulated Industries Training in the content and scope of quality systems is necessary to be an effective participant/leader in the regulated medical device industry. This training includes the evolution of quality system requirements and current perspectives on the interpretation of standards. 3 credits RAS 635. Regulatory Affairs Compliance Students will know the regulations associated with device product listing, facility registration, and product complaint management, and will become aware of other considerations associated with compliance, such as liability, root cause analyses, effective communication, and ethical considerations. 3 credits. Prerequisite: RAS 633. RAS 641. Health Policy and the Medical Technology Industry Students will gain a historical perspective of the role of health policy in the development and diffusion of medical technology. Policy issues will be framed in the context of promoting versus inhibiting technology development and diffusion. A major portion of this class is devoted to analysis and critique of current and proposed health policies as they affect the medical technology industry. 3 credits RAS 643. Cost Management of Regulated Health Care Technology Upon completion of the course, students will be able to describe the four basic types of economic evaluations and their intrinsic components as well as the modifications required based upon the perspective of the evaluation. They will also be able to critically appraise a published economic analysis of a medical technology. 3 credits. Prerequisite: RAS 641. RAS 645. Reimbursement for Medical Technology This is an overview of requirements for reimbursement for medical devices. Students will understand the relationship between the three components of reimbursement: coverage, coding and payment. Students will be able to state the basic components required to assess reimbursement for a new technology and be able to draft a preliminary strategy for gaining reimbursement. 3 credits. Prerequisite RAS 631. RAS 690. Regulatory Affairs Culminating Project The culminating experience consists of a research project, starred paper and seminar. Students will develop, carry out and report in written and oral format on an individual research project related to the content of the program courses. The project requires approval of the instructor. Students may take this course over one to three semesters, for a total of three credits. Required for degree. If you have further questions, please contact the College of Science and Engineering at 320.308.2192 or COSE@stcloudstate.edu Graduate Catalog (contact information) 720 4th Avenue South - St. Cloud, Minnesota 56301-4498 Page Revised: 8/8/2008 Phone: (320) 308-2113 © 2008 St. Cloud State University Site Map \| Map & Directions \| Contact SCSU \| Accreditations St. Cloud State University is an affirmative action/equal opportunity educator and employer. St. Cloud State University is a member of the Minnesota State Colleges and Universities system.

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