345192015 - Regulatory Affairs and Services

General

Program Title
Regulatory Affairs and Services
Degree Designation
GC
Program Level
Graduate
Instruction Mode
On Campus
Program Description
Catalog Description: The graduate certificate in Regulatory Affairs & Services offers foundational courses in regulatory affairs for medical devices. This graduate certificate is designed for those working in the medical device industry and those looking to enter this industry, including new graduates and working professionals, who will benefit from a basic education in medical device related regulatory requirements. The certificate is also an efficient transition option for students seeking the MS degree in Regulatory Affairs & Services.
Department(s)
Applied Education in MedTech Industry
College/School
College of Science and Engineering
Status
Active

Requirements

Learning Outcomes

Objective
Obtain and apply broad knowledge of domestic and international law, regulations, and guidance documents covering pre- and postmarket requirements for at least one category of medical products.
Objective
Examine quality systems and standards and their impact on product and public safety as well as the importance of quality products from the perspective of healthcare providers.
Objective
Present technical information and analysis in both oral and written forms.
Objective
Synthesize principles of medical device regulatory requirements, investigational device exemptions, regulatory submissions and compliance in a global society.
Objective
Use principles of experimental design, sample size estimation, and analysis methods to draft clinical trial protocols.

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