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Diploma of Medical Device Regulatory Affairs

Northeastern University

  • Boston, United States
  • 0.67 years
  • English
  • On campus
  • Diploma

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Northeastern University campus

About the program

A certificate on regulations governing commercialisation of medical devices across the product life cycle.

Program highlights

  • Internship available: no
  • Placement support: yes
  • Work during study: yes
  • Post-study work rights (0 year): no
  • PR pathway friendly: no

What you will learn

  • Develop subject knowledge in Medical Device Regulatory Affairs and apply relevant care or professional frameworks
  • Communicate effectively
  • And evaluate evidence-based practice.

Career outcomes

  • Healthcare Services Coordinator
  • Clinical Support Specialist
  • Health Program Associate
  • Healthcare Operations Analyst

Curriculum

  • Required courses are introduction to FDA medical device regulation
  • Medical device development: a regulatory overview
  • Medical device quality management systems and risk management compliance and processes
  • For 12 semester hours.

Entry requirements

Academic

  • Bachelor's degree (or equivalent)
  • Transcripts
  • Resume
  • Usually one recommendation letter
  • Foreign Credential Evaluation for non-US credentials.

Accepted academic background

Bachelor's degree (or equivalent), Transcripts, Resume, Usually one recommendation letter, Foreign Credential Evaluation for non-US credentials, Certificates do not by themselves satisfy language proficiency for later degree admission (CSSH).

Language tests

  • IELTS 6.5
  • TOEFL iBT 4
  • PTE Academic 53
  • Duolingo 105

Documents you’ll need

  • Academic Transcripts
  • Passport Copy
  • Recommendation Letters
  • CV or Resume.

How to apply

  1. Check the certificate's entry requirements
  2. English test minimums and deadline. Apply online through the graduate application and pay the 100 USD application fee. Upload official transcripts with a Foreign Credential Evaluation for non-US degrees
  3. Resume
  4. Usually one recommendation letter and TOEFL
  5. IELTS
  6. PTE or Duolingo scores. After admission
  7. Submit the I-20 request form with a passport copy. Apply for the F-1 visa with proof of funds.

Other costs

Tuition per year$15,540 USD
Application fee$100 USD
Deposit$600 USD

Program details

CampusBoston campus
Faculty or schoolCollege of Professional Studies
DepartmentMedical Device Regulatory Affairs
Teaching languageEnglish
Credit value12
Study paceFixed
Post-study stay0 year
Scholarship noteEligible Northeastern alumni may receive the Double Husky discount on qualifying graduate certificate courses, Parent and Family or Full Circle scholarships may apply only to qualified applicants and programs.

Frequently asked questions

  • The program takes 0.67 years.