Kristen Mittal

Kristen Mittal earned both her undergraduate and graduate degrees in biomedical engineering. She is certified in Regulatory Affairs (RAC) and Project Management (PMP) and serves on Drug and Device Advisory Committees for the University of Washington and Oregon Health & Science University.

Throughout her career, Kristen has worked across a range of sectors—from genetic engineering to various types of medical devices—providing her with a comprehensive understanding of the medical device technology landscape.

In her current role as Co-founder and CEO of Mittal Consulting, she leads a team that partners with Class I, II, and III medical device companies to support the full product lifecycle, from ideation through commercialization. Their work spans multiple device categories, including ophthalmologic, neurologic, gynecologic, orthopedic, radiologic, and AI-based technologies.

Mittal Consulting specializes in assisting startups and small manufacturers, with a strong emphasis on education and developing regulatory strategies that align with each company’s commercialization, marketing, and reimbursement objectives. The firm maintains partnerships with numerous universities and incubators across the US. Kristen also regularly delivers educational sessions on regulatory affairs at these institutions, helping to prepare the next generation of innovators for success in both regulatory science and medical entrepreneurship.