MSc Regulatory Affairs – Curriculum and Courses
March 20, 2026 2026-03-20 18:19MSc Regulatory Affairs – Curriculum and Courses
MSc in Regulatory Affairs & Quality Assurance in Medical Technologies — Curriculum & Courses
Program Overview
The Master of Science in Regulatory Affairs and Quality Assurance in Medical Technologies is a 30 credit hour program designed to prepare professionals for leadership roles in the medical technology industry. This comprehensive curriculum offers two specialized concentrations: Medical Devices and Pharmaceuticals.
Focus Areas: The program provides in-depth coverage of the regulatory landscape, compliance with laws, regulations, and international standards for medical devices and life sciences products. Students develop expertise in regulatory strategy, clinical trials management, quality assurance systems, risk management, product development processes, global regulatory frameworks, validation protocols, and regulatory auditing.
Core Courses (11 Courses)
The following core courses form the foundation of the MSc program and are required for all students:
| Course Code | Course Title | Credits | Prerequisites |
|---|---|---|---|
| HUM 500 | Ethics and Values Seminar | 2 | None |
| HUM 510 | Leadership, Teamwork and Success Principles | 2 | None |
| RAQ 500 | Introduction to Regulatory Affairs | 2 | None |
| RAQ 510 | Pharmaceutical and Medical Device Regulations | 2 | RAQ 520 |
| RAQ 520 | Quality Management Systems | 2 | RAQ 500 |
| RAQ 530 | Risk Management | 2 | RAQ 520 |
| RAQ 532 | Product Safety and Performance Testing | 2 | RAQ 520 |
| RAQ 600 | Medical Product Development Process | 2 | RAQ 520 |
| RAQ 514 | Medical Product Labeling Regulations | 2 | RAQ 520 |
| RAQ 710/720 | Internship or Capstone Project | 2 | Completed 20+ credits |
Elective Tracks
Students select one of three specialized tracks to complete their degree. Each track includes 10 credits of focused coursework in your area of specialization:
- BME 611 — Medical Devices 2 cr
- BME 630 — Engineering Compliance 2 cr
- RAQ 610 — Design Controls 2 cr
- RAQ 620 — Medical Device Regulations 2 cr
- RAQ 630 — 510(K) Premarket Notification Process 2 cr
- RAQ 640 — Pharmaceutical Regulations 2 cr
- RAQ 645 — Clinical Development of Drugs and Biologics 2 cr
- RAQ 650 — Biostatistics and Clinical Trial Design 2 cr
- RAQ 655 — Food Regulations 2 cr
- RAQ 660 — Regulatory Writing and Communication 2 cr
- RAQ 665 — Post Market Surveillance and Adverse Reporting 2 cr
- RAQ 670 — Clinical Evaluation Plan and Reporting 2 cr
- BME 627 — Science and Technologies in Healthcare 3 cr
Course Descriptions
Detailed course descriptions provide insight into the topics and skills covered in each course:
RAQ 500: Introduction to Regulatory Affairs
This foundational course provides an overview of the regulatory environment governing medical devices and pharmaceuticals. Students learn FDA organizational structure, drug and device approval pathways, regulatory submissions, clinical trial requirements, risk management frameworks, and intellectual property considerations essential for modern regulatory professionals.
RAQ 510: Pharmaceutical and Medical Device Regulations
Examine FDA and EMA regulatory frameworks for pharmaceuticals and medical devices, including drug development phases, clinical trial design and ethics, quality control standards, product labeling requirements, and pharmacovigilance systems. This course emphasizes global regulatory harmonization and compliance mechanisms.
RAQ 520: Quality Management Systems
Explore the principles and implementation of quality management systems including ISO 9001, Good Manufacturing Practices (GMP), and FDA Quality System Regulation (QSR). Students learn system planning, control mechanisms, quality assurance methodologies, and continuous improvement strategies essential for medical technology companies.
RAQ 530: Risk Management
This course covers comprehensive risk assessment and mitigation strategies across clinical, safety, and regulatory domains. Students develop competency in identifying potential hazards, evaluating risk severity, implementing mitigation controls, and conducting post-marketing surveillance to ensure patient safety throughout the product lifecycle.
RAQ 532: Product Safety and Performance Testing
Learn the methodologies and regulatory guidelines for safety and performance testing of medical devices. Topics include in vitro and in vivo testing protocols, bench testing approaches, biocompatibility assessment, and interpretation of test results according to FDA guidelines and international standards.
RAQ 600: Medical Product Development Process
This course examines the stages of medical device and pharmaceutical development from concept to commercialization. Students analyze regulatory requirements at each stage, study real-world development case studies, and explore factors contributing to development successes and failures in the medical technology industry.
RAQ 514: Medical Product Labeling Regulations
Master FDA labeling regulations including requirements for product markings, instructions for use, user manuals, and promotional content. Students learn how to develop compliant labeling that communicates safely to healthcare providers and patients while meeting all regulatory requirements.
RAQ 610: Design Controls
Comprehensive coverage of FDA Design Control regulations and ISO 13485 design lifecycle requirements. Students learn design planning, design verification, design validation, design transfer, and design change protocols essential for developing compliant medical devices that meet user needs and regulatory standards.
RAQ 620: Medical Device Regulations
In-depth examination of FDA and European Union device regulations, including device classification systems, premarket submission pathways (510k, PMA, De Novo), post-market surveillance obligations, and international regulatory requirements for global market access.
RAQ 630: 510(K) Premarket Notification Process
Specialized course focusing on the 510(k) regulatory pathway for medical device clearance. Students learn the legal and regulatory framework, 510(k) submission preparation, predicate device selection, substantial equivalence determination, and FDA review processes for this most common pathway to market.
RAQ 640: Pharmaceutical Regulations
Comprehensive overview of the pharmaceutical product lifecycle from discovery through post-marketing surveillance. Topics include drug development phases, investigational new drug applications, new drug applications, regulatory approval processes, and ongoing compliance obligations for marketed pharmaceutical products.
RAQ 645: Clinical Development of Drugs and Biologics
Examine the clinical development phases (Phase I-IV) for drugs and biologics, including trial design methodologies, informed consent requirements, ethical review processes, and regulatory documentation. Students gain insight into the complexities of bringing new therapeutics to market.
RAQ 650: Biostatistics and Clinical Trial Design
Master statistical methods and study design principles fundamental to clinical trials. Topics include hypothesis testing, study design types, sample size calculations, survival analysis, and interpretation of clinical data to support regulatory submissions and post-marketing studies.
RAQ 655: Food Regulations
Learn food safety regulations, production oversight requirements, and hazard analysis procedures. This course covers FDA food facility registration, dietary supplements regulation, and compliance strategies for companies operating at the intersection of food and medical devices.
RAQ 660: Regulatory Writing and Communication
Develop expertise in regulatory document preparation including submissions to regulatory agencies, technical reports, standard operating procedures, and scientific writing. Students learn to communicate complex regulatory information clearly and persuasively to diverse audiences.
RAQ 665: Post Market Surveillance and Adverse Reporting
Comprehensive coverage of post-market surveillance obligations including adverse event reporting, MedWatch procedures, complaint handling, and risk-benefit analysis. Students learn strategies for ongoing product monitoring and regulatory compliance after market launch.
RAQ 670: Clinical Evaluation Plan and Reporting
Master the development and documentation of clinical evaluation plans and clinical data reporting requirements. This course covers European Clinical Evaluation Plan standards, clinical data documentation, and preparation of comprehensive clinical reports for regulatory submissions.
BME 627: Science and Technologies in Healthcare
Explore emerging medical sciences and healthcare technologies including medical imaging systems, surgical robotics, digital health platforms, and biotechnology innovations. This course provides context for the regulatory challenges posed by new medical technologies.
BME 611: Medical Devices
Survey of diagnostic and therapeutic medical devices, including device materials, manufacturing processes, sterilization methods, and performance specifications. Students gain practical knowledge of device engineering and manufacturing that informs regulatory strategy.
BME 630: Engineering Compliance
Explore engineering approaches to regulatory compliance including framework analysis, documentation practices, and quality procedures. Students learn how engineering and regulatory functions collaborate to develop compliant medical device designs.
Frequently Asked Questions
What is the total credit requirement for graduation?
The MSc in Regulatory Affairs and Quality Assurance in Medical Technologies requires 30 credit hours for completion. This includes 22 credits of core courses, 8 credits from your selected elective track, and concludes with either a capstone project or internship experience.
Can I pursue both device and pharmaceutical specializations?
Students select one primary track (Medical Devices, Pharmaceuticals, or General Electives) to maintain program focus and depth. However, elective flexibility allows selection of courses from other tracks subject to prerequisite completion and advisor approval.
Are there prerequisites for course enrollment?
Yes, several courses have prerequisites. Most advanced regulatory affairs courses require completion of RAQ 500 and RAQ 520. Prerequisites are designed to build foundational knowledge systematically. Check specific course listings for detailed prerequisite requirements before registration.
What is the difference between the capstone project and internship?
RAQ 710 (Capstone Project) is a research-focused experience where students complete an independent project on a regulatory affairs topic. RAQ 720 (Internship) provides hands-on experience working with an industry organization. Students select one option based on their career interests and availability.
Can I take courses outside my selected track?
Yes, with advisor approval, students may take electives from other tracks or general electives. This provides flexibility to explore diverse regulatory topics while maintaining the coherent depth of your primary specialization track.
Ready to Start Your Journey?
Begin your career in regulatory affairs and quality assurance in medical technologies. Our comprehensive curriculum prepares you for leadership roles in this dynamic field.
