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# Device Cybersecurity Firm Hires Former FDA Reviewer
- URL: https://www.fdaweb.com/device-cybersecurity-firm-hires-former-fda-reviewer/
- Published: 2022-08-30T12:00:00.000Z
- Updated: 2026-09-14T17:57:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152625

Medical device cybersecurity consulting firm MedCrypt has hired former CDRH Diabetes Diagnostics Device Branch lead reviewer **Naomi Schwartz** as the firm’s new senior director of cybersecurity quality and safety. With six years of device review experience at CDRH and over 20 years of systems engineering experience, Schwartz at MedCrypt will “lead the analysis of cybersecurity designs for medical devices and help medical device manufacturers (MDMs) optimize their cybersecurity framework to meet guidelines set by the FDA,” the company says.

She will also evaluate manufacturer and cybersecurity processes to develop tools that will improve cybersecurity integration into quality management systems and reduce the burden and uncertainty of postmarket management, MedCrypt says.

At FDA, Schwartz approved the software and cybersecurity for the world’s first regulated automated insulin dosing (AID) System and created Class 2 pathways for the three major components of AID systems, MedCrypt says. “Prior to that, Naomi spent 15 years supporting the Department of Defense as a contractor, specializing in radar system requirements and performance analyses, system design, and independent verification and validation.”