Medical Device Regulatory Affairs and Quality Systems

BMG 501 Medical Device Regulatory Affairs and Quality Systems is a graduate-level course designed to equip students with a deep understanding of the global regulatory framework governing medical devices. It covers critical topics such as the classification of medical devices, various premarket submission pathways, and the essential components of a compliant quality management system. The course delves into the principles and practical application of internationally recognized quality system standards, emphasizing risk management, design control, and post-market surveillance. Through a blend of theoretical instruction and hands-on laboratory exercises, students will develop the skills necessary to ensure regulatory compliance and uphold product safety and efficacy throughout the medical device lifecycle, preparing them for leadership roles in regulatory affairs and quality assurance.

Course outline

Lectures, virtual labs, and graded assignments — completed in your browser.

01Lesson 1: Introduction to Medical Device Regulation and Global Harmonizationlecture

02Lesson 2: Medical Device Classification and Risk-Based Approacheslecture

03Lesson 3: Premarket Pathways: Types and Requirementslecture

04Hands-on Lab: Device Classification and Pathway Determinationlab

05Lesson 5: Essential Principles of Safety and Performancelecture

06Lesson 6: Introduction to Quality Management Systems for Medical Deviceslecture

07Lesson 7: Management Responsibility and Resource Management in QMSlecture

08Hands-on Lab: QMS Documentation and Process Mappinglab

09Lesson 9: Product Realization: Planning, Design, and Development Controlslecture

10Lesson 10: Production and Service Provision, Control of Nonconforming Productlecture

11Hands-on Lab: Risk Management Application and Design Control Documentationlab

12Lesson 12: Measurement, Analysis, and Improvement: Internal Audits and Corrective Actionslecture

13Lesson 13: Post-Market Surveillance and Vigilance Reportinglecture

14Capstone Service Project: Developing a Regulatory Strategy and QMS Frameworkassignment

Syllabus

["Week 1: Lesson 1: Introduction to Medical Device Regulation and Global Harmonization","Week 2: Lesson 2: Medical Device Classification and Risk-Based Approaches","Week 3: Lesson 3: Premarket Pathways: Types and Requirements","Week 4: Hands-on Lab: Device Classification and Pathway Determination","Week 5: Lesson 5: Essential Principles of Safety and Performance","Week 6: Lesson 6: Introduction to Quality Management Systems for Medical Devices","Week 7: Lesson 7: Management Responsibility and Resource Management in QMS","Week 8: Hands-on Lab: QMS Documentation and Process Mapping","Week 9: Lesson 9: Product Realization: Planning, Design, and Development Controls","Week 10: Lesson 10: Production and Service Provision, Control of Nonconforming Product","Week 11: Hands-on Lab: Risk Management Application and Design Control Documentation","Week 12: Lesson 12: Measurement, Analysis, and Improvement: Internal Audits and Corrective Actions","Week 13: Lesson 13: Post-Market Surveillance and Vigilance Reporting","Week 14: Capstone Service Project: Developing a Regulatory Strategy and QMS Framework"]