Graduate Certificate in Medical Devices Regulatory Affairs

Module Descriptions

Module 1 (OTH531): Introduction to Global Medical Device Regulation and Quality and Compliance

This introductory course provides key foundational information related to the global regulation of medical devices with emphasis placed on ASEAN, EU and Asia-Pacific countries. Additionally, the role of the global regulatory professional will be examined in the context of these regulatory frameworks. Covering pertinent subtopics such as harmonization, ethics and legal perspectives, the course will prepare students for more in-depth examinations of submissions and the development of regulatory strategy.

This course will also provide foundational information related to the concepts of compliance and quality in the context of the global regulatory framework. Emphasis is placed on Quality System Regulations (QSRs), Good Manufacturing Practices (GMPs), Good Distribution Practices (GDPs), process validation, supply chain management including supplier qualification, and risk management. The module will increase the students’ understanding of the critical role quality and compliance have in supporting good regulatory practices

Following are the topics that will be covered:

  1. Role of the Regulatory Profession and Professional
  2. Medical Devices: Definition and Lifecycle
  3. Professional Ethics
  4. Quality: A Primer for the Regulatory Professional
  5. Compliance
  6. Incorporation of Quality and Compliance Into Regulatory Strategy