RQM+ Live! is a weekly and interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device industry. Please view our blog for a other shows, along with other RQM+ events and learning opportunities.
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Whether you're on your first 510(k) submission at a startup or your 50th at a large company, you likely have some anxiety over the unpredictability of the process. Let our submission experts will help ease your mind! The panel includes recent CDRH staff who will discuss their tips and tricks for a smooth 510(k) submission process.
We'll cover best practices in all aspects of 510(k) submissions:
Content
Compilation
Format
Internal review
Communication with FDA
Refuse-To-Accept (RTA) issues
Fulfilling requests for additional information
Please bring your questions!
Here's the panel:
Nancy Morrison — Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q
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