St. Cloud State University

MS-RAS Course Narratives

Official Graduate School course descriptions available here

RAS-621: Legal Basis for Medical Device Product Regulation

This introductory course is designed to provide the basis for the U.S. Food and Drug Administration (FDA) regulation of medical devices. FDA’s mission, history and organization are reviewed. FDA regulatory requirements for medical devices and combination products are covered, along with the basics of FDA regulation of drugs and biologics. The role of regulatory, clinical and quality functions within a company is discussed. 3 credits.

RAS-623: Investigational Medical Device Regulations, Standards and Guidelines

This course covers FDA’s regulation of the clinical evaluation of medical devices under the Investigational Device Exemption (IDE) regulation and the subsequent market approval of these devices under the Pre-Market Approval (PMA) regulation. The content and approval process for IDE and PMA applications are presented. Clinical aspects associated with conducting a successful clinical trial as well as ethical and global requirements are discussed. Humanitarian use of medical devices and other exceptions are considered. 3 credits.

RAS-625: Regulatory Submission/Application Requirements for Medical Devices: Routes to Market

This course presents the major U.S. routes to market for medical devices with a detailed discussion of the Pre-Market Notification (510(k)) regulation and requirements and an overview of the PMA regulation and requirements. Best practices associated with the preparation and approval of regulatory submissions are presented. Developing regulatory strategies for the global market introduction is discussed. 3 credits.

RAS-627: International Regulatory Affairs: European Union, Canada, Japan and Australia

This course covers international regulatory systems for medical devices with emphasis on the European Union, Japan, Canada and Australia. Regulatory requirements for each system are presented including classification, marketing submission and post-approval requirements. Regulatory requirements in other countries are reviewed. Organizing and planning to meet the challenges of global regulation is considered. 3 credits.

RAS-631: Clinical Study Design, Implementation and Analysis

This course covers the general principles associated with conducting medical device clinical research and evaluation. Epidemiological and bio-statistical factors are presented. The most common study designs are discussed along with their scientific and practical advantages and disadvantages. Defining clinical objectives for target audience (FDA, payers, physicians, patients) is discussed. The logistics of conducting clinical studies are reviewed. 3 credits.

RAS-633: Quality Systems for Regulated Industry

This course covers quality systems applicable to the medical device industry with emphasis on the FDA’s Quality Systems Regulation and the international ISO 13485 Standard. Other applicable quality systems are overviewed including drug good manufacturing practices (GMPs), good laboratory practices (GLPs) and good clinical practices (GCPs). Applicability of quality systems to medical device design, manufacturing and post-market surveillance is discussed. Internal auditing and regulatory inspections are reviewed. The role of the quality organization is discussed. 3 credits.

RAS-635: Regulatory Affairs Compliance

This course provides an overview of FDA law and regulations applicable throughout a medical device product life cycle, including penalties for non-compliance. Strategies and ethical considerations for establishing an organizational culture of compliance are discussed. Methods for monitoring post-market device performance including root cause analysis, corrective and preventive actions and product recalls are presented. Strategies for effective communication of negative information and minimizing liability are discussed. 3 credits.

RAS-641: Health Policy and the Medical Technology Industry

This course covers the effect of health policy on the medical device industry and the development and diffusion of medical technology. The historical development of health policy affecting device regulation, reimbursement and grant funding is presented. A model is presented for analyzing how policy issues promote or inhibit the development and diffusion of medical technology. Current and proposed health policies are analyzed and critiqued for their impact on medical technology. 3 credits.

RAS-643: Cost Management of Regulated Health Care Technology

This course covers the economics of health care and how it is different from other markets. The relationship between access to health care technology and health is discussed. The process and components for economic evaluations of medical technology are presented. Impact of economic evaluations on reimbursement decisions is discussed. Current economic evaluations are reviewed and critiqued. 3 credits.

RAS-645: Reimbursement for Medical Technology

This course covers the process for reimbursement of medical devices. The three components of reimbursement, coverage, coding and payment, are presented and their interdependencies discussed. The process and principles for the development of clinical and reimbursement strategies to address the three components of reimbursement are presented. 3 credits.

RAS-690 Regulatory Affairs Culminating Project

This course applies the knowledge from program courses into practical experience. A project is identified with an instructor. The student conducts necessary background research, develops the project scope and completes the project. Project completion includes a written report and an oral presentation. The course may cover one to three semesters. 3 credits.

	A-Z Index \| News \| Library \| Technology \| Support St. Cloud State \| St. Cloud State University Home Admissions Academics Student Life About SCSU Athletics Alumni & Friends Home About RAS Courses Location Schedule Faculty Advisory Board Apply Contact MS-RAS Course Narratives Official Graduate School course descriptions available here RAS-621: Legal Basis for Medical Device Product Regulation This introductory course is designed to provide the basis for the U.S. Food and Drug Administration (FDA) regulation of medical devices. FDA’s mission, history and organization are reviewed. FDA regulatory requirements for medical devices and combination products are covered, along with the basics of FDA regulation of drugs and biologics. The role of regulatory, clinical and quality functions within a company is discussed. 3 credits. RAS-623: Investigational Medical Device Regulations, Standards and Guidelines This course covers FDA’s regulation of the clinical evaluation of medical devices under the Investigational Device Exemption (IDE) regulation and the subsequent market approval of these devices under the Pre-Market Approval (PMA) regulation. The content and approval process for IDE and PMA applications are presented. Clinical aspects associated with conducting a successful clinical trial as well as ethical and global requirements are discussed. Humanitarian use of medical devices and other exceptions are considered. 3 credits. RAS-625: Regulatory Submission/Application Requirements for Medical Devices: Routes to Market This course presents the major U.S. routes to market for medical devices with a detailed discussion of the Pre-Market Notification (510(k)) regulation and requirements and an overview of the PMA regulation and requirements. Best practices associated with the preparation and approval of regulatory submissions are presented. Developing regulatory strategies for the global market introduction is discussed. 3 credits. RAS-627: International Regulatory Affairs: European Union, Canada, Japan and Australia This course covers international regulatory systems for medical devices with emphasis on the European Union, Japan, Canada and Australia. Regulatory requirements for each system are presented including classification, marketing submission and post-approval requirements. Regulatory requirements in other countries are reviewed. Organizing and planning to meet the challenges of global regulation is considered. 3 credits. RAS-631: Clinical Study Design, Implementation and Analysis This course covers the general principles associated with conducting medical device clinical research and evaluation. Epidemiological and bio-statistical factors are presented. The most common study designs are discussed along with their scientific and practical advantages and disadvantages. Defining clinical objectives for target audience (FDA, payers, physicians, patients) is discussed. The logistics of conducting clinical studies are reviewed. 3 credits. RAS-633: Quality Systems for Regulated Industry This course covers quality systems applicable to the medical device industry with emphasis on the FDA’s Quality Systems Regulation and the international ISO 13485 Standard. Other applicable quality systems are overviewed including drug good manufacturing practices (GMPs), good laboratory practices (GLPs) and good clinical practices (GCPs). Applicability of quality systems to medical device design, manufacturing and post-market surveillance is discussed. Internal auditing and regulatory inspections are reviewed. The role of the quality organization is discussed. 3 credits. RAS-635: Regulatory Affairs Compliance This course provides an overview of FDA law and regulations applicable throughout a medical device product life cycle, including penalties for non-compliance. Strategies and ethical considerations for establishing an organizational culture of compliance are discussed. Methods for monitoring post-market device performance including root cause analysis, corrective and preventive actions and product recalls are presented. Strategies for effective communication of negative information and minimizing liability are discussed. 3 credits. RAS-641: Health Policy and the Medical Technology Industry This course covers the effect of health policy on the medical device industry and the development and diffusion of medical technology. The historical development of health policy affecting device regulation, reimbursement and grant funding is presented. A model is presented for analyzing how policy issues promote or inhibit the development and diffusion of medical technology. Current and proposed health policies are analyzed and critiqued for their impact on medical technology. 3 credits. RAS-643: Cost Management of Regulated Health Care Technology This course covers the economics of health care and how it is different from other markets. The relationship between access to health care technology and health is discussed. The process and components for economic evaluations of medical technology are presented. Impact of economic evaluations on reimbursement decisions is discussed. Current economic evaluations are reviewed and critiqued. 3 credits. RAS-645: Reimbursement for Medical Technology This course covers the process for reimbursement of medical devices. The three components of reimbursement, coverage, coding and payment, are presented and their interdependencies discussed. The process and principles for the development of clinical and reimbursement strategies to address the three components of reimbursement are presented. 3 credits. RAS-690 Regulatory Affairs Culminating Project This course applies the knowledge from program courses into practical experience. A project is identified with an instructor. The student conducts necessary background research, develops the project scope and completes the project. Project completion includes a written report and an oral presentation. The course may cover one to three semesters. 3 credits. College of Science and Engineering (contact information) 720 4th Avenue South - St. Cloud, Minnesota 56301-4498 Page Revised: 6/24/2008 Phone: (320) 308-2192 © 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. 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