Certificate in Medical Device Regulatory Affairs at Northeastern University

Northeastern University

United States of America, Boston

University Rank:#384

The Medical Device Regulatory Affairs is a Certificate degree offered by Northeastern University across its Boston and Online campuses in United States of America. The program is delivered on campus as a Full Time course in English and requires approximately 1 year to complete. Students study across its Boston and Online campuses while gaining the knowledge and practical experience expected for this area of study. The next intake is available from January 1, 2027.

About Certificate in Medical Device Regulatory Affairs

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.

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Unique Features

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

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

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

Requirements and Admission Criteria for Certificate in Medical Device Regulatory Affairs at Northeastern University

Entry Requirements

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

English Requirements

PTEMin 76
IELTSMin 8
TOEFLMin 108

English Program Requirements

Northeastern students will be exposed to not only a rigorous academic environment but also a fast-paced experiential one. In order to be successful in both, all first-year and transfer applicants, regardless of citizenship, must demonstrate proficiency in English to be considered for admission to Northeastern.

Once your application is submitted, received, and processed, you will be able to access your Application Status Check. If you are required to provide further information regarding your proficiency in English, you will be able to complete the requirement in several ways, depending on your familiarity with English, and the frequency with which you use English each and every day:

Non-native English-speaking applicants will be required to submit official and valid results from one of the following English Language Tests:
- C1 Advanced or C2 Proficiency (Cambridge English)
- Duolingo English Test (DET)
- IELTS Academic
- PTE Academic
- TOEFL Internt-based Test (CEEB Code: 3667) Northeastern will accept either the in-person version completed in a test center, or the TOEFL iBT Home Edition
However, based on your academic environment and the primary instructional language in either your high school or university, you may be eligible for a waiver. All waivers must be submitted through your Application Status Check. For additional information and to determine whether or not you are eligible for a waiver, please read the section below on waiving the English proficiency requirement.

Please note: Northeastern’s Admissions Committee reserves the right to request proof of English language proficiency from any applicant, regardless of citizenship or first language, at any time during the evaluation process.

Tuition and Fee Information for Certificate in Medical Device Regulatory Affairs at Northeastern University

Application Fee 75

How to Apply for Certificate in Medical Device Regulatory Affairs at Northeastern University

1.Create your application
Submit your application through The Common Application or the Coalition Application (both are accepted). Once you have created your application, please select Northeastern University to directly submit your application to us. Application fee of $75 or need-based fee waiver* *Northeastern accepts need-based fee waivers from the Common Application, the Coalition Application, as well as organizations such as the College Board and ACT, or in a written request from a school official.
2.Submit all required materials
Double check to make sure that you have submitted all required materials. Even if your application has been submitted, we cannot begin reviewing your file until all of your required materials have been received. For applicants applying for the 2022-2023 academic year, Northeastern University is test-optional and does not require standardized testing to complete an application for admission.
3.Check your application status
Within seven days of applying, you should receive a confirmation email containing your Northeastern University ID number and instructions for setting up your Application Status Check account. To ensure all of the necessary documents have been submitted, and for updates or information about your application, visit your application status check.

Certificate in Medical Device Regulatory Affairs at Northeastern University

Northeastern University

United States of America, Boston