Certificate in Regulatory Affairs in Medical Devices

The certificate has several goals:Provide curricular guidance to undergraduate students on careers in the regulatory affairs field for medical devices. Provide curricular guidance for understanding regulatory affairs requirements and processes related to medical device design, development and manufacture for students entering medical device industry, governmental agencies, or pursuing entrepreneurship opportunities.Provide additional credentialling that builds on B.S. degree in engineering and technology programs.Learning Outcomes:The student will recognize and understand FDA regulatory nomenclature.The student will understand the federal regulations and quality standards in the approval process of a medical device.The student will be able to understand and use regulatory application and report forms.The student will be able to identify and navigate the basic regulatory steps in the development process for medical devices.The student will be able to identify basic responsibilities of the regulatory affairs processional that extend throughout the lifetime of medical device.

Required Transcripts: Applicants must arrange for the Office of Undergraduate Admissions and Orientation to receive official copies of academic records of the applicant’s attendance at secondary school, college, university, and professional institutions of learning. These transcripts must be sent directly from the high school or college to the University of Memphis. An exception is made for those who hold the bachelor’s degree or its equivalent in that they need not send their secondary school records. Records should list the subjects studied and the grade, mark, or other evidence that each individual subject was completed to the satisfaction of the authorities in charge. If it is impossible for the school to send us an official copy, copies certified by an official at the American Embassy or a known world organization may be acceptable. All records must be in English. Since certificates and records filed for examination are not ordinarily returned, applicants should send certified copies if the documents in question cannot be easily replaced.Freshman Test Required: Applicants to the first year undergraduate level must submit scores on the Scholastic Aptitude Test (SAT) or the American College Testing Program (ACT). These tests are available only in English. All test scores should be sent directly from the testing agency or the high school to the University of Memphis.Required Test of English Proficiency, for Non-English Speaking Applicants: All applicants whose native language is not English or their primary education was not taught in English must demonstrate English proficiency. The Test of English as a Foreign Language (TOEFL) or the International English Language Testing System (IELTS) are the standard methods to satisfy the English proficiency requirement. All other methods should be approved by the Office of Admissions and Orientation. The minimum overall TOEFL score considered for undergraduate admission to the University of Memphis is sixty-one (61) on the internet-based test (iIBT) or five hundred (500) on the paper-based test (PBT). The equivalent score on the IELTS is a six (6). TOEFL information may be obtained by writing: TOEFL, Educational Testing Service, Princeton, New Jersey, 08540, U.S.A. IELTS information may be found at their website https://www.ielts.org. All test scores must be sent directly from the testing agency to the University of Memphis.Outstanding high school students who have completed the sophomore year may be admitted and register for one college course per term of enrollment concurrently provided they supply evidence of the following: