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Regulatory Affairs and Services

General

Testing

Program Title

Regulatory Affairs and Services

Degree Designation

GC

Award Type

Post-Baccalaureate Certificate

Program Level

Graduate

Instruction Mode

On Campus

Program 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 who will benefit from 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.

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

Minimum undergraduate GPA for admission

2.75

Other requirements applicants MUST complete prior to admission.

An undergraduate degree in engineering, science, biochemistry, biostatistics, public health, nursing or other appropriate and relevant areas is recommended.

Admission to SCSU Graduate School.

The GRE is not required.

Required GPA for graduation

3

Minimum Course Grade Applies To

All courses in a select course prefix/rubric

Number of credits in program

16

Requirements

Program Learning Outcomes

Outcome

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.

Outcome

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.

Outcome

Present technical information and analysis in both oral and written forms.

Degree Maps

Major Code

8197

Program Code

345192015