MaiQuyen Nguyen is a Principal Consultant at CardioMed Device Consultants and a former FDA Lead Reviewer with six years of experience in cardiovascular medical device regulation and involvement in more than 500 regulatory submissions. She combines FDA regulatory insight with biomedical engineering expertise to help manufacturers navigate complex regulatory requirements, develop effective preclinical testing strategies, and advance Class II and Class III devices toward FDA clearance and approval. Her expertise includes vascular and endovascular technologies, durability testing, and device verification and validation.
Experience
Ms. Nguyen served on the Vascular and Endovascular Devices Team within FDA’s Office of Cardiovascular Devices, reviewing Pre-Submissions, Breakthrough Device Designation requests, IDEs, 510(k)s, PMAs, PMA supplements, and postmarket compliance matters. Her expertise includes preclinical testing, clinical study design, and regulatory evaluation of novel thoracic aortic and aortic arch devices. She also contributed to ISO and ASTM standards development and presented at scientific conferences, including ASAIO and Stent Summit.
Prior to joining the FDA, Ms. Nguyen conducted biomedical engineering research focused on cardiovascular tissue characterization, artificial lung technologies, computational fluid dynamics (CFD), and finite element analysis. Her technical experience includes computational modeling, accelerated mechanical testing, and large-animal GLP studies.
At CardioMed, Ms. Nguyen advises manufacturers on FDA regulatory strategy, preclinical testing requirements, device performance evaluation, and regulatory submissions, combining firsthand FDA review experience with practical biomedical engineering expertise.