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College of Professional Studies

Medical Device Regulatory Affairs

Certificate

The Graduate Certificate in Medical Device Regulatory Affairs provides in-depth knowledge of the regulations and standards, global applications, and social impact of the medical device industry.

Program curriculum Explore College of Professional Studies
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Program Format
Online
Time Commitment
Part Time
Duration
6 - 12 Months
Entry Term(s)
Fall, Spring, Winter
Meets F1 visa requirements
No
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Program overview

The future of medical devices

The Graduate Certificate in Medical Device Regulatory Affairs online program presents an in-depth review of regulations relating to the development of medical devices, including those products not specifically regulated by federal law. Working and collaborating online, students will conduct a practical, in-depth analysis on how emerging developments and trends are reshaping the regulation of medical devices in the U.S., as well as reviewing global markets and regulations. This graduate program also examines related legal issues, such as intellectual property, patents, and licensing, and considers the social and financial impact of the medical device industry on the aging population.

 

Please note: Beginning fall 2026, this program will shift from a quarter-based academic calendar to a semester format. View the program conversion guide for curriculum details or visit our FAQ page for more information.

If you enter this program before fall 2026, your academic advisor will work with you to ensure a smooth transition. This change will not impact your academic progress, path to graduation, or tuition costs.

  • Online program provides flexibility and freedom to working professionals
  • 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

Admissions

Apply to the program

A graduate degree or certificate from Northeastern can accelerate your career through rigorous academic coursework and real-world professional experience in your area of interest. Apply to take your career to the next level.

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:

Domestic Application Guidelines

International Application Guidelines*

*International deadlines are only applicable if the program is F1 compliant.


  • Online application

  • Professional resumé

  • Unofficial undergraduate transcripts; official transcripts required at the time of admission

    • The Foreign Credential Evaluation (FCE) is a required assessment of all transcripts and documents from non-U.S. accredited post-secondary education institutions. (Review the FCE requirements by country.)

  • 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

  • Other materials may be required

Program objectives

Prepare for success

In-depth knowledge

Build your foundation in medical device regulations and standards, global applications of the medical device industry, and emerging developments and trends.

A people-first approach

Understand the social and financial impact of the medical device industry on the aging population.

Degree building

Stack your certificate

Earning a graduate certificate is a fast and affordable way to acquire specialized skills while building toward your master’s degree. Upon completion of this certificate program, you may be able to apply your credits to an eligible master’s program, saving time and money on your degree.

Some of the eligible master’s programs for this certificate include:

Contact an enrollment counselor to learn more about eligibility requirements.

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Cost of attendance

Tuition and financial aid

  • $15,120
    Tuition in USD

Estimated Total Tuition

This is an estimate based on the tuition rates for Academic Year 2025-2026 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. Select programs at select campuses offer additional scholarships of up to 25% off the listed price for domestic students studying on campus. For more detailed information, please visit Student Financial Services.

For students interested in pursuing financial assistance or educational loans, additional educational costs, known as Cost of Attendance (COA) components, can be included in the calculation of aid and loan eligibility. Components may include food, housing, books, course materials, supplies, equipment, transportation, personal expenses, and the cost of obtaining a first professional licensure. You can find comprehensive details on the Student Financial Services website. Please keep in mind that COA can vary significantly depending on academic program, enrollment intensity, and individual circumstances.

There are many ways to pay for your education, including scholarships, financial aid, and more. Connect with a financial counselor to learn about your options and make your dream a reality.

Visit tuition & financial aid
Online Programs

Your education, your way

A person with curly hair in a white zip-up jacket sits at a modern kitchen table, focused on their laptop. They hold a mug and appear engaged, with natural light filtering through a window behind them.

Northeastern's online classes give you the same top-tier education you'd get in person, on a schedule that works for your lifestyle and career needs. They offer a range of videos, interactives, breakout sessions, and experience-focused learning opportunities to immerse you in the material and build community. You'll graduate with the same degree as your in-person peers.

Learn more about online learning at Northeastern

#8

Northeastern's national ranking for Most Innovative Schools

(U.S. News & World Report, 2024)

53.5%

Percent of graduate students in the U.S. enrolled in online courses

(NCES, 2022)

97%

Percent of students in the U.S. who recommend online education

(BestColleges, 2024)

Connect with us

Want more information?

We’re here to answer your questions about this program, the application process, and more. Complete the form below to receive additional program details and speak with a member of our enrollment team. 

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