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United States Medical Device Regulations – a Comprehensive Overview

NSF International
Training overview
2 hours
From 399 USD
Next start date: Inquire for more information - Online

Course description

United States Medical Device Regulations – a Comprehensive Overview

This course comprehensively covers regulatory requirements including the regulatory framework, pre and post market requirements, and instruction on the way the U.S. is utilizing MDSAP. All courses include competency assessment and a Certificate of Successful Completion for your training files.

Training Content


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.

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Certification / Credits


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

About NSF International

NSF International

NSF International

NSF Health Sciences partners with life science companies, big and small, to provide highly customized end-to-end services throughout the product lifecycle. From early development to commercial manufacture and distribution, our expert services will assist you to: Ensure regulatory compliance Implement...

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Contact info

NSF International

789 N. Dixboro Road
48105 Ann Arbor Michigan

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