Graduate Certificate in Medical Devices Regulatory Affairs

Module Descriptions

Module 2 (OTH729): Medical Device Regulation in the United States and European Union

The module delves into medical device regulation in the US, with an emphasis on the product lifecycle and an extended examination of the submissions process in the US. Key sub-topics include interactions with the US Food and Drug Administration (FDA), submission types (e.g., PMAs and 510(k)s) and postmarketing.

This course also provides a comprehensive review of medical device regulation in the EU, with an emphasis on the product lifecycle and an extended examination of the submissions process in the EU. Key sub-topics include clinical assessment of medical devices, the Medical Devices Directive (MDD), conformity assessment pathways and the impact of harmonization efforts on the region.

Following are the topics that will be covered:

  1. Overview of US Medical Device Regulation
  2. Device Development, Quality Systems and Agency Interactions
  3. Clinical Evaluations of Medical Devices
  4. Marketing Submissions
  5. Advertising, Labeling and Promotion
  6. Post-Market Surveillance and Vigilance for Medical Devices
  7. Overview of EU Medical Device Regulatory Structure
  8. Medical Devices Directives (MDD)
  9. In Vitro Diagnostic Devices Directive (IVDD) and Active Implantable Medical Devices Directive (AIMDD)