Medical Device Regulation
General
Program Title
Medical Device Regulation
Degree Designation
GC
Award Type
Post-Baccalaureate Certificate
Program Level
Graduate
Instruction Mode
On Campus
Program Description
The graduate certificate in Medical Device Regulation offers foundational courses in regulatory, quality and clinical research 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, quality, and clinical research requirements.
Department/Unit(s)
College/School
College of Science and Engineering
Status
Active
Admission Requirements
What previous degree and/or experience is required prior to admission to this program?
Bachelors Degree
Requirements
Free Form Requisites
Admissions Requirements
An undergraduate degree in engineering, science, biochemistry, biostatistics, public health, nursing or other appropriate and relevant areas is recommended.
Undergraduate GPA 2.75
Accepted into SCSU Graduate School.
The GRE is not required.
Program Requirements (16-18 credits)
Core (12 Credits): course or course; course or course; course, course
Electives: Select 4-6 credits from the following: course, course, course, course, course, course, course, course.
See program website for additional information.
Program Learning Outcomes
Outcome
Describe and discuss the role of medical devices and combination products in diagnosing, mitigating, managing, and curing medical disease and conditions, including their modes of action, and adverse effects.
Outcome
Describe the life cycle of a medical product as well as as the roles and responsibilities of clinical research, regulatory affairs and quality professionals throughout the life cycle.
Outcome
Classify medical devices and identify their regulatory path to market in the US, EU, and other geographies.
Outcome
Classify medical devices and identify their regulatory path to market in the US, EU, and other geographies.
Outcome
Identify and apply the codes of ethics that apply to medical device professionals, and in particular those related to conducting clinical research on human subjects.
Outcome
Identify and apply the codes of ethics that apply to medical device professionals, and in particular those related to conducting clinical research on human subjects.
Outcome
Apply the principles of Good Documentation Practices.
Outcome
Demonstrate use of appropriate terminology and acronyms used in the clinical research of medical devices.
Outcome
Demonstrate use of appropriate terminology and acronyms used in the clinical research of medical devices.
Degree Maps
Major Code
8196
Program Code
340622015