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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 Device 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 review 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.
- Boston location on flagship campus—a hub for healthcare, education, finance, business, biotechnology, and the life sciences
- Choose from elective courses that cover a broad range of practical and relevant issues in the field
- Courses from this certificate can be applied toward the Master of Science in Regulatory Affairs
Get Set With a Custom Course Plan
Please note: The following is a sample curriculum and is subject to change. Enrolled students should reference the academic catalog for current program requirements.
Complete the appropriate number of electives to obtain minimum quarter hours required for the program:
Now Let's Talk Admissions
You know where you are headed and you've seen how our program will lead you there. So let's get going. Here's what you need to know before you enroll.
- Online application
- Statement of purpose (500–1000 words): identify your educational goals and expectations of the program; please be aware that Northeastern University's academic policy on plagiarism applies to your statement of purpose
- Professional resumé
- Unofficial undergraduate transcripts (official transcripts required at the time of admission)
- English language proficiency proof: students for whom English is not their primary language must submit one of the following:
- Official associate or bachelor's degree transcript from an accredited college or university in the U.S, stating degree conferral and date
- TOEFL, IELTS, PTE, Duolingo, or NU Global Exam scores
Are You an International Student? Find out what additional documents are required to apply.
Admissions Details Learn more about the College of Professional Studies admissions process, policies, and required materials.
Cost and Tuition
Estimated Total Tuition
This is an estimate based on the tuition rates for Academic Year 2022-2023 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. For more detailed information, please visit Student Financial Services.
Our admissions process operates on a rolling basis; however, we do recommend the application guidelines below to ensure you can begin during your desired start term:
*International deadlines are only applicable if the program is F1 compliant.
Student Body Profile
Below is a look at where our Regulatory Affairs alumni work, the positions they hold, and the skills they bring to their organization.
Where They Work
- Teva Pharmaceuticals
What They Do
- Quality Assurance
- Healthcare Services
What They're Skilled At
- Regulatory Affairs
- Pharmaceutical Industry
- U.S. Food and Drug Administration
- Clinical Trials
- Standard Operating Procedure (SOP)
Learn more about Northeastern Alumni on Linkedin.