14 courses with the subject RAS, each shown exactly as we captured it from the college's catalog, with every element we hold. Where the wording looks broken, that is our reading of the catalog, not the college's text.
Credit for independent research by a single student arranged and supervised by a faculty member. Not intended for culminating project research such as thesis or starred paper.
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.
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. Pre-Requisite(s): RAS621
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. Pre- Requisite(s): RAS621
& Canada [Credits: 3] 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.
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. Pre-Requisite(s): RAS621
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.
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. Pre-Requisite(s): RAS633
[Credits: 3] 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.
Credit for off-campus professional experience with industry partners, non-profit organizations or government agencies. Can serve as a graduate culminating experience in conjunction with a portfolio demonstrating mastery of associated learning outcomes. Pre- Requisite(s): ACR622, RAS621, RAS627, RAS623, RAS631, RAS633
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. Pre-Requisite(s): RAS623, RAS625, RAS633
Middle East [Credits: 3] 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.
Experimental, temporary or trial course for groups of students all engaged in the same topic. Topic varies from semester to semester or section to section. A specific content offering may be offered under a topics course number up to three times, after which departments must file for a permanent course number. According to Graduate School 276
A graduate only course that is used for completion of the culminating project of a Master's Degree, including Master's Thesis, Starred Paper and Creative Work. Six credits total are required for graduation for Thesis and Creative Work. Three credits are normally required for Starred Paper.
Source: Saint Cloud State University's catalog, linked per course · table learning_unit · CourseShelf publish 61
