Naomi Schwartz, MS
Medcrypt, Inc., San Diego, California
Naomi is the Vice President at Medcrypt, a medical device cybersecurity firm. Naomi was a premarket reviewer and consumer safety officer in CDRH for 6.5 years focused on software, interoperability, cybersecurity and wireless coexistence for connected diabetes devices.
Prior to that, Naomi was a defense contractor (for. 15 years) developing radar systems for the US DoD.
While at FDA, Naomi reviewed a first-of-kind automated insulin dosing system; helped develop Class II Pathways for 3 separate connected diabetes devices (iCGM ACE pump and iAGC) to support innovation in diabetes device development with clear regulatory expectations; helped craft standards including IEEE P2621.1-.3: standards and recommended practice for wireless diabetes device security assurance evaluation, security requirements and use of mobile devices in control contexts; and managed postmarket triage for cybersecurity vulnerability disclosure in diabetes devices and IVDs.