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RAS 600. Special Problems

Credits: 1-3 View Details
Description: Independent study is available for advanced students wishing to work out a special problem in the major area of concentration. May be repeated to a maximum of three credits.
Semester Offered:
  • Fall
  • Spring
  • Summer


RAS 621. Legal Basis for Medical Device Product Regulation

Credits: 3 View Details
Description: Upon completion of this course the students will be knowledgeable about the objective and structure of the FDA, key regulations associated medical devices, and the resources available from the FDA to aid in compliance with those regulations.
Semester Offered:
  • Fall
  • Spring


RAS 623. Regulatory Routes to Market: 510(k)s

Credits: 3 View Details
Description: U.S. route to market for medical devices, the Premarket Notification of 510(k), and regulation and requirements. Best practices associated with the preparation and clearance of Premarket Notifications. Developing regulatory strategies for markets.
Prerequisites: RAS 621
Semester Offered: DEMAND


RAS 625. Regulatory Routes to Market: PMA's

Credits: 3 View Details
Description: U.S. route to market for high risk medical devices, Pre-Market Approval Application (PMA) and Pre-Market Approval regulation and requirements. Best practices associated with the preparation and approval of PMAs. Developing regulatory strategies for markets.
Prerequisites: RAS 621
Semester Offered: DEMAND


RAS 627. Intl Regulatory Affairs: European Union, East Europe, Australia & Canada

Credits: 3 View Details
Description: International regulatory affairs for medical devices with emphasis on the European Union (EU), Eastern Europe, Australia and Canada Regulatory requirements. Classification, marketing submissions, and pre- and post-market approval requirements. Regulatory strategies for global market introduction and planning for the challenges of global regulation.
Semester Offered: DEMAND


RAS 631. IDE Regulations and Clinical Trial Design

Credits: 4 View Details
Description: Conducting clinical research on unapproved medical devices. Pre and post market approval requirements and logistics of conducting clinical trials. Principles of clinical trial design. Common study designs and scientific and practical advantages and disadvantages. Clinical Trial Life Cycle.
Prerequisites: RAS 621
Semester Offered: DEMAND


RAS 633. Quality Systems for Regulated Industries

Credits: 3 View Details
Description: Training in the content and scope of Quality Systems necessary to be an effective participant/leader in the regulated medical device industry, the evolution of quality system requirements and current perspectives on the interpretation of standards.
Semester Offered:
  • Fall
  • Summer


RAS 635. Regulatory Affairs Compliance

Credits: 3 View Details
Description: Students will be knowledgeable about the regulations associated with device product listing, facility registration, product complaint management, aware of other considerations associated with compliance such as liability, root cause analyses, effective communication, and ethical considerations.
Prerequisites: RAS 633
Semester Offered:
  • Fall
  • Spring


RAS 641. Health Policy and the Medical Technology Industry

Credits: 3 View Details
Description: Historical perspective of the role of health policy in the development and diffusion of medical technology. Policy issues framed in the context of promoting versus inhibiting technology development and diffusion. A major portion of class will be devoted to analysis and critique of current and proposed health policies as they affect he medical technology industry.
Semester Offered:
  • Fall
  • Summer


RAS 643. Reimbursement & Cost Management for Medical Technology

Credits: 3 View Details
Description: Reimbursement and the role of health economics in the adoption of medical technology. Coverage, coding and payment, and their interdependencies. Economic evaluations for medical technology and the impact of economic evaluations on reimbursement decisions.
Semester Offered: DEMAND


RAS 644. Regulatory Affairs Internship

Credits: 1-6 View Details
Description: Professional experience in the medical device industry. May be repeated up to a total of 6 credits.
Prerequisites: RAS 621, RAS 633, ACR 622, RAS 623, RAS 631, RAS 627
Semester Offered:
  • Fall
  • Spring
  • Summer


RAS 651. Regulation of Combination Products

Credits: 3 View Details
Description: Regulatory requirements for combination products that include medical devices and drugs or biologics. FDA procedures for determining how combination products are regulated and applicable pre- and post-market requirements. International requirements for combination products.
Prerequisites: RAS 623, RAS 625, RAS 633
Semester Offered: DEMAND


RAS 653. Regulatory and Clinical Ethics Involving Medical Devices

Credits: 3 View Details
Description: Analyzing and responding to ethical issues affecting patients, physicians, government regulators and customers. Applicable codes of conduct, regulations and guidances.
Prerequisites: RAS 621, RAS 631
Semester Offered: DEMAND


RAS 655. International Reg Affairs: Japan, Other Asia, Latin America & Middle East

Credits: 3 View Details
Description: International medical device regulations, regulatory requirements and trends; classification, marketing submissions and post-approval processes. Developing, planning, and organizing regulatory strategies for successful global markets.
Semester Offered: DEMAND


RAS 690. Capstone Culminating Project

Credits: 1-2 View Details
Description: Background research and project scope. Written report and oral presentation.
Semester Offered:
  • Spring
  • Summer






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