18 Nov The Capital Network “Life Science Fast Track”
November 18, 2014 Boston, MA
Mack Rubley, Vice President Consulting Services at BBA spoke at the Life Science Venture Fast Track event on November 18, 2014 in Boston on the topic of Regulatory Strategy. The meeting was attended by entrepreneurs and investors of medtech start up companies. The focus of the presentation was on developing your regulatory strategy, determining the Class of your medical device, and how to effectively utilize the 510(k) and PMA databases on the FDA website. During the presentation, Mack provided tools for determining regulatory requirements, and utilizing predicate information to develop 510(k) and PMA submissions to the FDA. Finally, he provided tips on when to engage in discussions with the FDA prior to submission and after.