To update and strengthen the RAS Curriculum, a comprehensive review has been conducted under the leadership of Chuck Swanson, RAS Program Director, with the support of the expert RAS faculty and Advisory Board. The objective has been to identify new courses and course improvements. The new RAS program has 33 credits including eight core and two elective classroom courses plus the culminating project. The inclusion of electives will allow students to better tailor their program to individual needs.
The new RAS Program curriculum has been implemented starting with the Fall 2010 RAS student cohort. The initial RAS Program curriculum is being phased out with the last course being offered summer semester 2011.
33 Credits
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.
This course covers the major U.S. route to market for medical devices, the Pre-market Notification of 510(k). The Pre-market Notification regulation and requirements are discussed in detail. Best practices associated with the preparation and clearance of Pre-market Notifications are presented. Developing regulatory strategies for market introduction are discussed. 3 credits.
This course covers the US route to market for high risk medical devices, the Pre-market Approval Application or PMA. The Pre-Market Approval Regulation and requirements are discussed in detail. Best practices associated with the preparation and approval of PMAs are presented. Developing regulatory strategies for market introduction are discussed. 3 credits.
This course covers international regulatory systems with emphasis on the European Union, Eastern Europe, Australia and Canada. Regulatory requirements for each system are presented including classification, marketing submission and post-approval requirements. Developing regulatory strategies for global market introduction and organizing and planning for the challenges of global regulation are considered. 3 credits.
This course covers the principles associated with clinical evaluation of medical devices. Pre- and post-approval requirements under the IDE regulation and the logistics of conducting a regulated clinical trial are discussed. Principles of clinical trial design including clinical objectives, epidemiological and statistical considerations are presented. Common study designs are discussed along with their scientific and practical advantages and disadvantages. 4 credits.
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 over viewed 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.
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.
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.
This course covers the basic principles of reimbursement and economics for medical technology. The three components of reimbursement, coverage, coding and payment, and their interdependencies are presented. The principles of economic evaluations for medical technology and the impact of economic evaluations on reimbursement decisions are discussed. 3 Credits.
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 two semesters. 2 credits
This course covers regulatory requirements for combination products that include medical devices and drugs or biologics. Students will learn FDA procedures for determining how combination products are regulated and how to identify pre- and post-market requirements. Students will also receive an introduction to international requirements for combination products. 3 credits.
This course provides a framework for analyzing and responding to ethical issues affecting patients, physicians, government regulators and customers. Applicable codes of conduct, regulations and guidances are presented and analyzed. Case studies involving medical devices with regulatory and ethical issues are presented and analyzed. 3 credits.
This course covers international regulatory systems for medical devices with emphasis on Japan, Other Asia, South America and the Middle East. Regulatory requirements for each system are presented including classification marketing submission and post-approval requirements. Developing regulatory strategies for global market introduction and organizing and planning to meet the challenges of global regulation is considered. 3 credits.
This course covers the detailed process associated with obtaining reimbursement and conducting economic evaluations for medical technology. The process and principles for the development of clinical and reimbursement strategies to address the three components of reimbursements are discussed. The process and principles assessing clinical data and conducting economic evaluations for medical technology are presented. 3 credits.
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