Discover how to successfully navigate the complex world of medical device regulations with Kristen Mittal, RAC, PMP — Co-Founder and CEO of Mittal Consulting. In this episode, Kristen shares insights from over a decade of experience working with startups and Fortune 500 companies, specializing in Class I, II, and III medical devices.
From achieving rapid FDA clearances to building strong post-market strategies, Kristen has become a trusted advisor in the MedTech space. She also discusses how her firm supports early-stage innovators through FDA and EU submissions, commercialization strategies, and regulatory planning.
As a member of advisory committees at OHSU, the University of Washington, and UCSF, Kristen is deeply involved in shaping the future of healthcare innovation.


