April Training Workshop: Making sense of FDA Land in Submissions (510(k)s, De novos, and PMAs)

This workshop will take the beginning regulatory affairs professional and the veteran through the basics of medical device submissions to FDA. The speakers Mark Duval and Lisa Pritchard will share with the audience insights as to how their firm DuVal & Associates makes submissions that are designed to succeed and avoid wasting time and making common mistakes. The speakers have hundreds of submissions under their belt and are at the FDA physically about three times per month representing clients in pre-sub, 510(k), de novo and PMA negotiations. Their relationships with FDA and the knack for persuading FDA to their clients’ position are their stocks-in-trade.
Helping clients be appropriately aggressive, yet compliant. TM