Kristen Mittal

Kristen Mittal, RAC, PMP, is the co-founder and CEO of Mittal Consulting, a premier regulatory affairs consulting firm dedicated to guiding medical device innovators through complex regulatory landscapes. With over a decade of experience spanning startups to Fortune 500 companies and hands-on expertise in Class I, II, and III medical devices, Kristen has built a reputation for delivering efficient regulatory strategies, rapid FDA clearances, and robust post-market solutions. At Mittal Consulting, she leads a team specifically tailored to early-stage ventures providing comprehensive support from FDA and EU submissions to innovative commercialization strategies. Kristen’s commitment to empowering entrepreneurs, providing industry education, and bridging medical innovation with regulatory expertise has made her a trusted advisor and sought-after speaker in the MedTech community. She currently sits on the Oregon Health and Science University (OHSU) and the University of Washington Drug and Device Advisory Committees as well as the University of California San Francisco (UCSF) Rosenman and MedtechWOMEN committees.