Quality Assurance in Biomedical Product Regulation

  • Certificate
Location: Boston
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Why Quality Assurance for Biomedical Products?

The Graduate Certificate in Quality Assurance for Biomedical Products provides an in-depth knowledge of the global regulatory and compliance requirements for the development, marketing approval, and clinical utilization of biomedical products in today’s dynamic global healthcare environment.

The Graduate Certificate in Quality Assurance for Biomedical Products prepares you to navigate the compliance aspects of industry-specific regulatory standards throughout their product lifecycle.

In this program, students will have the opportunity to achieve the following learning outcomes:

  • Describe the general standards utilized by the United States Food and Drug Administration (FDA) and other global regulatory agencies to evaluate the safety and efficacy of existing and new biomedical products utilized by healthcare practitioners in the U.S. market
  • Demonstrate proficiency in the application of compliance-associated regulations and standards for global biomedical products throughout their life cycle
  • Differentiate between the distinct stages of the global biomedical product commercialization process from regulatory and standards-based compliance perspectives
  • Detail the fundamental regulatory compliance and standards-based processes under which biomedical products must be manufactured in order to maintain the level of safety and efficacy upon which they were approved for marketing by FDA and other global regulatory agencies

Unique Features

  • Choose from elective courses that cover a broad range of practical and relevant issues in the field
  • The BTC 4450 Quality Control and Validation Issues course was developed in collaboration with quality assurance professionals from Vertex Pharmaceuticals and other external pharmaceutical industry partners
  • Courses from this certificate can be applied toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices

What you'll study

General Requirements

Quality Assurance in Biomedical Product Regulation General Requirements

Required Courses

RGA 6000 - Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation
RGA 6001 - Introduction to Food and Drug Administration (FDA) Medical Device Regulation
RGA 6002 - Introduction to Regulatory Compliance and Practice
RGA 6275 - Product Development and Process Validation


Complete a minimum of 8 quarter hours from the following:

BTC 6210 - Human Experimentation: Methodological Issues Fundamentals
BTC 6211 - Validation and Auditing of Clinical Trial Information
RGA 6233 - Application of Quality System Regulation in Medical Device Design and Manufacturing
RGA 6234 - Risk Management: Compliance and Processes
RGA 6462 - Regulatory Compliance in the Pharmaceutical Industry: A Collaborative Approach

This program requires successful completion of a minimum of 16 credit hours that meet the degree requirements.

Did You Know?

A graduate certificate can boost your earnings by an average of 25% (Washington Post, 2012).

Did You Know?

About 137,000 new regulatory affairs jobs were filled in 2018.

Average Time to Completion

1 year



Entry Terms


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