Free on-demand webinar

How to Navigate 7 Common Challenges in 510(k) Submissions

Ever struggle with the complexities of the 510(k) submission process? Want to avoid costly and time-consuming mistakes in your premarket notification?

In this free, on-demand webinar, we provide clear, expert-informed guidance on 510(k) submissions.

We cover:

  • The often-overlooked aspects of the 510(k) process
  • Demonstrating substantial equivalence effectively
  • Providing sufficient documentation to the FDA
  • Proactively addressing FDA questions and concerns
  • Writing clear and concise content for FDA reviewers
  • Understanding the review timeline

About the Presenter

Trey Thorsen, MS, RAC

Trey-modifiedTrey is an experienced regulatory affairs consultant who has helped numerous startups and mid-size medical device companies clear their Class I, II, and III devices for the U.S. market.

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