Graduate Certificate in Medical Devices Regulatory Affairs

Campus Locations Boston, Online
Also available 100% Online Yes
Other Format(s)
Credits Required for Graduation 16
Entry Terms Fall Quarter, Winter Quarter, Spring Quarter, Summer Quarter (excl F1 visa applicants)
Meets International Visa Requirements Yes


The medical device industry has continued to experience healthy market growth despite the sluggishness of the national economy. In fact, the industry's support of research and development efforts is expected to top $194 billion this year. There are over 7,000 medical device companies in the United States, and nearly 1,000 of these are based in Massachusetts. In total, the medical device sector in Massachusetts employs 36,000 workers, has a payroll of over $1.8 billion, and annual shipments of $7.3 billion.

The Graduate Certificate in Medical Devices Regulatory Affairs provides an in-depth knowledge of the regulations and standards that apply to the development of medical devices, including those products not specifically regulated by federal law. The program will reviews the global applications of the medical device industry. Students will conduct practical, in-depth analysis on how emerging developments and trends are reshaping medical devices regulation in the U.S. The program also focuses on the social and financial impact of the medical devices industry on the aging population.

Courses from this certificate may be applied toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices.


Required Courses (8 q.h.) 

RGA 6202 Medical Device Development, A Regulatory Overview 4 q.h.
RGA 6205 Emerging Trends and Issues in the Medical Device Industry 4 q.h.

Elective Courses (8-9 q.h.)

Choose two of the following courses:

BTC 6260 The Business of Medicine and Biotechnology 4 q.h.
RGA 6211 Combination Products and Convergence  4 q.h.
RGA 6112 Biomedical Intellectual Property Management: Patents, Trademarks, Copyrights, Trade Secrets, and Technology Licensing  4 q.h.
RGA 6222 Global Awareness: European Medical Device Regulations 4 q.h.
RGA 6225 Japanese Medical Device Regulations and Registrations 4 q.h.
RGA 6226 Canadian and Australian Medical Device Regulations 4 q.h.
RGA 6227 Global Awareness: Emerging Medical Device Markets 4 q.h.
RGA 6203 Food, Drug, and Medical Device Law: Topics & Cases  5 q.h.
TCC 6370 Regulatory Writing: Medical Device Submissions 4 q.h.
ITP 6305 Technology Licensing  4 q.h. 


Total Quarter Hours: 16-17

Admissions Requirements

Below are the official Admissions Requirements for this program.

  • Online application
  • Statement of purpose (500-1000 words): identifying your educational goals and expectations from the program; please be aware that the University's academic policy on plagiarism applies to applicant's statement of purpose
  • Professional resume: Current resume that displays job responsibilities, relevant experience, and education history
  • Official undergraduate degree documentation
  • Proof of English language proficiency: ONLY for students for whom English is not their primary language: English language proficiency guidelines

For general admissions information and recommended admissions deadlines, Graduate Admissions.

All requirements must be received prior to review.


Estimated total tuition for this program is $9,776.00.

Tuition for individual courses is based on the number of quarter hours. Most courses are 3-6 quarter hours. See Graduate Tuition Rates for details.

Use our Tuition Calculator below to see if transfer credit or tuition reimbursement from your employer could reduce your total tuition.

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Please note: The estimated total tuition is based on tuition rates for Academic Year 2014-15 and does not include any fees or other expenses. Some courses and labs have tuition rates that may increase or decrease total tuition. Tuition and fees are subject to revision by the president and Board of Trustees at any time.

*A maximum of 9 quarter hours of graduate- or doctoral-level credit obtained at another institution may be awarded as Advanced Graduate Credit to the Doctor of Education program.

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Next Term Starts
  • Spring Term
    Apr 6, 2015 (12- and 6-week classes)
    May 18, 2015 (6-week classes)

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