Graduate Certificate in Medical Device and Technologies Regulation

Overview

The Graduate Certificate in Medical Device and Technologies Regulations (MDTR) allows students to gain specialized knowledge and regulatory expertise for working in this area of the medical industry. The medical device industry supports a wide range of medical products, from simple syringes to complex MRI/PET imaging machines. With the advancement of technology, new areas such as wearable devices and digital devices have propelled growth in the field. The graduate certificate curriculum will require a total of 16 credit hours and will cover an overview of regulatory requirements for medical products, an overview of bioethics for research and development of medical products, good clinical practices, medical device development, and global medical devices. These courses are essential for workforce preparedness for a medical device regulatory professional.

Roles and Responsibilities of a Medical Device Regulatory Professional

• Outlining and evaluating the key stages of medical device development from concept through market launch.
• Applying Quality Management System (QMS) Principles to ensure regulatory compliance.
• Ensuring regulatory and compliance adherence where they identify and apply key medical device regulations and standards (e.g., ISO 13485, ISO 14971) throughout the development lifecycle.
• Developing and documenting design solutions by creating design inputs, outputs, and supporting documentation; evaluating material and component choices; and proposing design solutions that meet technical and regulatory requirements.
• Integrating human factors and usability studies, explaining how human factors influence design modifications, risk management, and overall product safety.
• Conducting prototype testing and verification plans, including biocompatibility evaluations, is necessary for product verification.
• Managing manufacturing and clinical investigation activities, including describing manufacturing requirements for investigational devices and outlining the essential components of clinical investigations.
• Preparing for regulatory submission and market launch, including developing intended use and indications for use statements, identifying submission requirements, and creating a launch plan that integrates regulatory, manufacturing, and marketing milestones.

Accreditations

The University of Georgia is accredited by the Southern Association of Colleges and Schools Commission on Colleges (SACSCOC) to award baccalaureate, master’s, specialist, and doctoral degrees. The University of Georgia also may offer credentials such as certificates and diplomas at approved degree levels. Questions about the accreditation of the University of Georgia may be directed in writing to the Southern Association of Colleges and Schools Commission on Colleges at 1866 Southern Lane, Decatur, GA 30033-4097, by calling (404) 679-4500, or by using information available on SACSCOC’s website (www.sacscoc.org).

Admissions

Admission Requirements

Online Graduate Certificate in Medical Device and Technologies Regulation Application Checklist:

1. Application – Submit the Graduate School Admissions online.  Application fee: $75.
2. Select Campus – Online 
3. Select Degree Level – Certificate
4. Select Intended Program – Grad Cert Medical Device  CERG, Medical Device and Technologies Regulations (College of Pharmacy) CERT_2MDT_GO
5. Select Intended Term – Fall or Spring
6. Résumé or curriculum vitae – Submit online to the Graduate School.
7. Statement of Purpose – Submit a one-to two-page statement of purpose online to the Graduate School. The statement of intent should clarify the candidate’s relevant background, interests, and goals in relation to the program.
8. Transcripts – Submit unofficial transcripts from all institutions attended as part of the online application. Send official transcripts after you are offered admission.
9. Letters of Recommendation – Submit two letters of recommendation online to graduate school. Letters should be from individuals who can evaluate the applicant’s scholarly ability and potential for success in a graduate program

Application Deadlines

Domestic Applicants

Fall: June 1

Spring: November 11

International Applicants

Fall: April 15

Spring: October 15

Cost

Tuition rates and student fees can change each year. (eRate Requested)

Based on the 2025 credit hour cost, a person completing this program at the recommended pace would have paid $ 12,160 in tuition.   Waiting on erate approval

Please use the Estimated Cost Calculator on the Bursar’s Office website to calculate one academic (Fall/Spring) year’s tuition. 

This program is an E-Rate program, so choose “yes” for the E-Rate line item within the calculator.

Fees for those students enrolled in exclusively online programs are $431 per semester. 

Potential additional costs include:

• Textbooks
• Exam proctoring fees
• Technology upgrades 

The complete cost of attendance can be found at the Office of Student Financial Aid.

Financial Aid

Visit the Office of Student Financial Aid for information about financial assistance.

Corporate Assistance

Consult your employer about the availability of tuition reimbursement or tuition assistance programs.

Military Assistance

Active-duty military, veterans, and military families should visit Veterans Educational Benefits to take full advantage of available financial assistance and educational benefits.

University System of Georgia Tuition Assistance Program (TAP)

The purpose of TAP is to foster the professional growth and development of eligible employees. For more information, see Tuition Assistance (refer to the Distance Learning section). 

Curriculum

16 semester hours to earn the Graduate Certificate in Medical Device and Technologies Regulations

Course	Title	Credit Hours
PHAR 6010E	Pharmaceutical, Biotechnology, and Device Industries	4
PHAR 6150E	Medical Device Development	3
PHAR 6310E	Good Clinical Practice Regulations for Drugs, Biologic Products, and Medical Devices	3
PHAR 6380E	Global Medical Device Regulatory Submissions – The Marketing Application Process	3
PHAR 7230E	Ethical Issues in Research	3

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