Decoding FDA Regulations: Pitfalls and Pearls for Medtech Entrepreneurs
Decoding FDA Regulations: Pitfalls and Pearls for Medtech Entrepreneurs
Join us for an online event where we'll dive into the world of FDA regulations and how they impact medtech entrepreneurs. This event will provide valuable insights and tips to help you navigate the medical device regulatory landscape as a startup founder.
Speaker: Kristen Mittal
Kristen Mittal received her undergraduate and master’s degrees in biomedical engineering from Arizona State University and she is also RAC and PMP certified. She spent time at a variety of companies throughout her career from genetic engineering to numerous types of devices to give her a broad perspective of the industry. In her current role as CEO of Mittal Consulting, her and her team work with a wide variety of class I, II and III medical device companies to bring them from ideation to commercialization. Over the last four years, some types of devices they’ve worked on have been ophthalmologic, neurologic, gynecologic, orthopedic, radiologic and AI. Mittal Consulting specializes in working with startups and small medical device manufacturers as a significant amount of time is invested in focusing on education and developing a regulatory strategy that is right for the company’s commercialization, marketing, and reimbursement goals. Mittal Consulting has partnerships with most University and Incubator programs on the west coast and Kristen regularly conducts regulatory educational events at these universities and incubator programs to help prepare the next generation to be successful in regulatory.
Company Bio
Mittal Consulting empowers small medical device manufacturers with seamless regulatory consulting services. They offer recognized expertise in assisting start-ups, universities, hospitals, and VC backed companies with cost-effective regulatory pathways to achieve long-term product success. With their proven proficiency in handling all classes of FDA and EU device submissions, Mittal Consulting’s team of highly trained professionals and ex-FDA consultants reduces the hassle for small ventures while building a strong device platform to support future company growth.