Kanchana Iyer

Kanchana Iyer is a regulatory affairs and quality strategy consultant specializing in medical devices, digital health, and emerging healthcare technologies. With experience spanning both the U.S. Food and Drug Administration (FDA) and industry, she brings a unique, systems-level perspective to product development integrating regulatory strategy, risk management, and evidence generation from concept through commercialization. Her work focuses on helping teams navigate complex regulatory pathways while building scalable, design-driven foundations that support long-term success At MEDIcept, Kanchana serves as a Principal Consultant, where she partners with clients across Medtech, biotech, and software-driven health companies to develop and execute regulatory strategies. Her work includes leading premarket pathway planning (510(k), De Novo, and PMA), supporting FDA interactions such as Q-Submissions, and guiding cross-functional teams through design controls, risk management, and clinical evidence development. She is also actively involved in supporting quality system readiness, audit preparation, and aligning technical documentation with global regulatory expectations, including EU MDR. Prior to joining MEDIcept, Kanchana held multiple roles across regulatory affairs and quality engineering, supporting a wide range of medical devices and combination products. She started her career at FDA, where she gained firsthand insight into regulatory review processes and expectations. Her experience spans software as a medical device (SaMD), cybersecurity considerations, clinical investigations, and global regulatory strategy. She has worked closely with engineering, clinical, and leadership teams to translate complex technical concepts into clear, compliant, and strategically aligned submissions. Kanchana holds a M.S. degree in Biomedical Engineering. She continues to focus her work at the intersection of innovation and regulation, particularly in AI/ML-enabled technologies and evolving global frameworks. She is passionate about advancing more thoughtful, integrated approaches to regulatory strategy that go beyond compliance to enable better products and outcomes.