Global Medical Device Regulatory Requirements – United States (2 hours)

This two-hour course provides a comprehensive overview of the regulatory requirements including the regulatory framework, pre- and post-market requirements, and the way the U.S. is utilizing MDSAP.

Key learning objectives:

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 pre-market regulations and pathways to market for medical devices in the United States
• Distinguish how the Food and Drug Administration (FDA) classifies medical devices
• Recognize when clinical data is required and the basic requirements for conducting clinical investigations
• Determine the application of post-market regulations, including quality systems (QMS) and adverse event reporting

This course is essential for anyone wanting to bring a medical device or IVD to market in this specific jurisdiction, and also for employees in regulatory, quality and compliance functions.