510(k) Premarket Notification Workshop – Bringing Medical Devices to the U.S. Market

  • Overview
  • On-Site Training
  • Who Should Attend?
  • Trainer Profile

The premarket notification, or 510(k) program, is one of FDA’s main premarket programs. The majority of medical devices sold in the United States are cleared for marketing under this program and knowing how to navigate its requirements is critical to a successful regulatory outcome. Understanding the 510(k) program and requirements allows companies to better prepare a submission to FDA to obtain clearance and compliant marketing of medical devices.

NSF’s on-site premarket notification 510(k) training course provides in-depth knowledge into the FDA’s 510(k) process and allows you to prepare your company for future regulatory submissions.

On-Site Training

In this two-day workshop, NSF’s team of experts will provide participants with a hands-on approach to understanding 510(k) basics, including how to construct a complete 510(k) submission direct from the perspective of a former FDA reviewer. This workshop also provides insight on how to communicate effectively with FDA via the pre-submission process. It takes you a step further on what to do when you have a cleared 510(k) device that needs modification, while considering risk management principles.

Who Should Attend?

This course is vital for any medical device regulatory professional as well as directors, managers and engineers involved in the regulatory lifecycle of a device.

Trainer Profile

NSF's medical devices training courses are taught by experts who have years of experience in medical device quality standards and regulatory requirements. Our trainers are committed to creating a learning environment that is highly interactive and based on real scenarios to help you apply practices and improve behaviors within your workplace. Learn more about our trainers for this premarket notification 510(k) course course:

Upcoming Courses & Webinars

In 510(k) Premarket Notification Workshop – Bringing Medical Devices to the U.S. Market
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