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.
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
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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