Naomi Schwartz

Naomi Schwartz serves as the Vice President of Services at Medcrypt, where she leverages her expertise in medical device regulation and cybersecurity. With over six years of experience at the FDA’s Center for Devices and Radiological Health, she has become a specialist in the regulation of medical devices, focusing on diabetes diagnostic and therapeutic technologies. Naomi played a pivotal role in developing new class II pathways to enhance regulatory science for interoperable diabetes devices. Her work has significantly expanded into dependable system design, evaluating aspects such as software, cybersecurity, and interoperability of medical devices. In 2016, she joined the FDA as a medical device regulator, with a focus on cybersecurity review. Later, she transitioned to Medcrypt to assist medical device manufacturers in improving their quality systems, embedding security throughout the device development lifecycle, and integrating postmarket data into premarket decisions and designs to maintain business reputation and stakeholder trust. Naomi holds an MS in Electrical and Computer Engineering from Carnegie Mellon University and is a Certified Quality Auditor. Her personal interests include a profound admiration for music legends like Billie Holiday, Nina Simone, and Janis Joplin, with whom she would love to have dinner.