DEVICE L❤️VE Live! #12 — July 2, 2020

Upcoming and on-demand education, commentary from thought leaders, Q&A features, and more.


 In the midst of the coronavirus pandemic and reduced travel/networking, please remember this page offers the latest virtual education, training, and industry information from R&Q. 

Tips and Tricks for a Smooth 510(k) Process

--- DEVICE L❤️VE 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 R&Q events and learning opportunities. ---

 

RQ_Device_Love_Live_12-min

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

  • Kevin Go — Senior Engineer (former FDA CDRH Lead Reviewer)
  • Bryan Pinder — Project Engineer (former FDA CDRH Lead Reviewer)
  • Michael Wolford —Senior Principal Specialist, R&Q