Overview

The medical device industry has continued to experience healthy market growth, with more than 7,000 medical device companies in the United States and nearly 1,000 based in Massachusetts alone. The Graduate Certificate in Medical Device Regulatory Affairs at Northeastern University provides in-depth knowledge of the regulations and standards that apply to the development of medical devices, including products not specifically regulated by federal law. The program will also review the global applications of the medical device industry and the social and financial impact of the medical devices industry on the aging population. Students will conduct practical, in-depth analysis on how emerging developments and trends are reshaping medical device regulation in the U.S.

Unique features

Study in Boston on our 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.

This program is visa-eligible at Northeastern University campuses in the United States and Canada.

Disclaimer: Visa eligibility may vary by location and individual circumstances. Applicants are responsible for verifying the most up-to-date visa regulations with the relevant visa or immigration agency before applying.

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Programme Structure

Courses included:

Medical Device Development: A Regulatory Overview
Application of Quality System Regulation in Medical Device Design and Manufacturing
Emerging Trends and Issues in the Medical Device Industry
European Medical Device Regulations
Medical Device Product Development in Canada
Product Development and Process Validation
Advanced Regulatory Writing: Medical Device Submissions

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Key information

Duration

Part-time
- 6 months

Start dates & application deadlines

Starting 2026-09-09 00:00:00
- Apply before 2026-08-03 00:00:00 , National
- Apply before 2026-07-06 00:00:00 , International
Starting 2027-01-07 00:00:00
- Apply before 2026-12-01 00:00:00 , National
- Apply before 2026-11-03 00:00:00 , International

Language

English

Duolingo English Test

105

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PTE Academic

Schedule a PTE test!

IELTS

6.5

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Credits

16 alternative credits

16 total quarter hours required

Delivered

On Campus

Campus Location

Boston, United States

Disciplines

Bio & Biomedical Engineering View 335 other Masters in Bio & Biomedical Engineering in United States

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Academic requirements

We are not aware of any specific GRE, GMAT or GPA grading score requirements for this programme.

English requirements

Duolingo English Test

105

Take A Free Practice Test!

PTE Academic

Schedule a PTE test!

IELTS

6.5

Prepare for Your English Test

Cathoven AI IELTS Preparation

Learn your IELTS Score

AI-powered IELTS feedback. Clear, actionable, and tailored to boost your writing & speaking score. No credit card or upfront payment required.

Trusted by 300k learners
98 accuracy using real exam data
4.9/5 student rating

Other requirements

General requirements

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

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Tuition Fees

Tuition fees are shown in and the most likely applicable fee is shown based on your nationality.

International Applies to you

Applies to you

Non-residents

15120 USD / full

≈ 15120 USD / full
Out-of-State

15120 USD / full

≈ 15120 USD / full
Domestic

Applies to you

In-State

15120 USD / full

≈ 15120 USD / full

Living costs

Boston

United States

1560 - 3239 USD / month

The living costs include the total expenses per month, covering accommodation, public transportation, utilities (electricity, internet), books and groceries.

Funding

Win a €10000 Scholarship! Deadline: 30 June 2020

Embark on your journey with the Studyportals Scholarship! We're giving away a total of 20,000 euros to help you achieve your dream of studying abroad.

Win a €10000 Scholarship! Deadline: 30 June 2020

Embark on your journey with the Studyportals Scholarship! We're giving away a total of 20,000 euros to help you achieve your dream of studying abroad.

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Scholarships Information

Below you will find Master's scholarship opportunities for Medical Device Regulatory Affairs.

Available Scholarships

You are eligible to apply for these scholarships but a selection process will still be applied by the provider.

On this page

About

Overview

Unique features

Get more details

Programme Structure

Check out the full curriculum

Key information

Duration

Start dates & application deadlines

Language

Prepare for Your English Test

Credits

Delivered

Campus Location

Disciplines

Explore more key information

What students do after studying

Academic requirements

English requirements

Prepare for Your English Test

Other requirements

General requirements

Make sure you meet all requirements

Tuition Fees

International Applies to you

Domestic

Living costs

Boston

Funding

Check for any work restrictions

Scholarships Information

Available Scholarships

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