Medical Device Regulatory Requirements - United States (2 hours)

1 module



Course Length
120 mins

NSF Medical Devices



A comprehensive overview of the U.S. Medical Device regulatory framework, including both Premarket AND Postmarket requirements.  Learn what it takes to bring a product to the U.S. market and KEEP it there! You’ll also be introduced to the Medical Device Single Audit Program (MDSAP), and learn how the U.S. is utilizing MDSAP.  Includes competency assessments to provide documented evidence for the training requirements of ISO 13485:2016, the International Quality Management System Standard.


By the end of this course, you should:

  • Understand the legal and regulatory framework for developing, marketing, and distributing medical devices.
  • Understand the Medical Device Single Audit Program (MDSAP) and its function in the United States.
  • Identify the premarket regulations and pathways to market for medical devices.
  • Distinguish how the Food & Drug Administration (FDA) classifies medical devices.
  • Recognize when clinical data is required and the basic requirements for conducting clinical  investigations.
  • Determine the application of postmarket regulations, including quality systems (QSM) and adverse event reporting.


By completing/passing this course, you will attain the certificate Medical Device Certificate

US Regulatory Requirements
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Good course, with lots of good information.
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