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 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.

Watch the webinar on-demand and access the slide deck—all free. 👇