On-demand

Mastering your 510(k) submission process (On-Demand)

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This is an On-Demand webcast from November 2022.

Bringing a Class II medical device to the American market? You’ll need to go through the 510(k) process, your gateway to FDA clearance. Yet many businesses are getting it wrong: successful applications are falling, and 30% of 2021 applications weren’t even accepted for initial review.

A robust 510(k) plan is crucial for a smooth and speedy route to market. This webinar gives you everything you need to know to become a 510(k) master.

Learning Objectives

• Understand the optimal pathway to follow for right-first-time, stress-free 510(k) clearance.
• Learn the most common mistakes the FDA sees in applications, and how to avoid them.
• Unpick the key ingredients of a 510(k) submission, from predicate devices and substantial equivalence to typical timelines.

Who Should Attend?

Regulatory Affairs Professionals

Speakers:

Kyle Rose, Rock Quality Systems

Questions

Contact the RAPS Support Center: 

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.