February 6-8, 2018Anaheim Convention CenterAnaheim, CA
2018 Event Content Schedule
Use the scheduling tool below to browse all the available sessions, speakers and topics at this year's event. Find the content and sessions to fit all of your educational needs and ensure you get the most out of your time at the show.
Preparing the contents of the 510(k) submission and going through the review process with FDA is far from easy. Getting a device ready for 510(k) submission can be time-consuming, costly, and full of challenges. Going through a review process with FDA is likely to take longer than expected and result in additional expenses to address their questions. But getting that letter from FDA stating you have successfully received market clearance can make it all worth it! In this session, you’ll learn how to better prepare and help facilitate a faster clearance.
Topics to be covered include:
Understanding FDA 510(k) reviewer expectations
Techniques to increase the likelihood of a successful product submission
Exploring the relationship between quality systems regulation and the 510(k) submission