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Naomi Schwartz
Senior Director of Cybersecurity Quality and Safety at MedCrypt
Potomac, MD, United States
Details
Education:
BS/MS
Electrical & Computer Engineering
Carnegie Mellon University
1995 : 2001
PhD
Electrical Engineering
Virginia Polytechnic Institute and State University
2002 : 2009
BS
Russian Studies & Anthropology
Carnegie Mellon University
1991 : 1995
Electrical & Computer Engineering
Carnegie Mellon University
1995 : 2001
PhD
Electrical Engineering
Virginia Polytechnic Institute and State University
2002 : 2009
BS
Russian Studies & Anthropology
Carnegie Mellon University
1991 : 1995
Experience:
At MedCrypt I evaluate cybersecurity designs for medical devices and provide gap analyses and regulatory strategies for balancing benefit-risk, development time and cost to meet regulatory expectations and provide secure and safe devices to patients and healthcare providers. We provide services and products that support secure device design and implementation.
2022 : Present
MedCrypt
Senior Director of Cybersecurity Quality and Safety
Primary reviewer of diabetes digital health technologies and software reviewer for de novos granted to create Class II pathways for integrated continuous glucose monitoring (iCGM) system, alternate controller enabled (ACE) infusion pump, and interoperable automated glycemic controller (iAGC)
Consulting reviewer for software as a medical device (SaMD) mobile medical apps (MMAs) throughout DCTD including mobile apps utilizing novel software-based image processing and registration methodologies to achieve consistent results reading test strips in a mobile device-agnostic setting
Consulting reviewer for software as a medical device (SaMD) mobile medical apps (MMAs) utilized in combination products overseen by OHT3 including connected insulin injection pens that communicate to bolus dose calculators, blood glucose meters and/or continuous glucose monitoring systems
Advises branch and division management on interpreting and applying the guidance document “Multiple Function Device Products : Policy and Considerations,” the 21st Century Cures Act, and the guidance document “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act” to ensure a least burdensome approach to reviewing software that consists of both device and non-device functionality and in determining which software no longer is regulated per Cures
Advises management on technical and regulatory issues involving in vitro diagnostic devices (IVDs), particularly electromagnetic compatibility, wireless coexistence, software, artificial intelligence/machine learning applications and mobile medical apps (MMAs)
2016 : 2022
FDA
Scientific Reviewer, Consumer Safety Officer
2013 : 2016
Leidos, Inc
Senior RF Systems Engineer
We perform requirements analyses, performance analyses, system designs and field testing of a variety of radio frequency devices in support of several government customers.
2007 : 2013
SAIC
Senior RF Systems Engineer
2001 : 2006
Northrop Grumman Corporation
Engineer
2022 : Present
MedCrypt
Senior Director of Cybersecurity Quality and Safety
Primary reviewer of diabetes digital health technologies and software reviewer for de novos granted to create Class II pathways for integrated continuous glucose monitoring (iCGM) system, alternate controller enabled (ACE) infusion pump, and interoperable automated glycemic controller (iAGC)
Consulting reviewer for software as a medical device (SaMD) mobile medical apps (MMAs) throughout DCTD including mobile apps utilizing novel software-based image processing and registration methodologies to achieve consistent results reading test strips in a mobile device-agnostic setting
Consulting reviewer for software as a medical device (SaMD) mobile medical apps (MMAs) utilized in combination products overseen by OHT3 including connected insulin injection pens that communicate to bolus dose calculators, blood glucose meters and/or continuous glucose monitoring systems
Advises branch and division management on interpreting and applying the guidance document “Multiple Function Device Products : Policy and Considerations,” the 21st Century Cures Act, and the guidance document “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act” to ensure a least burdensome approach to reviewing software that consists of both device and non-device functionality and in determining which software no longer is regulated per Cures
Advises management on technical and regulatory issues involving in vitro diagnostic devices (IVDs), particularly electromagnetic compatibility, wireless coexistence, software, artificial intelligence/machine learning applications and mobile medical apps (MMAs)
2016 : 2022
FDA
Scientific Reviewer, Consumer Safety Officer
2013 : 2016
Leidos, Inc
Senior RF Systems Engineer
We perform requirements analyses, performance analyses, system designs and field testing of a variety of radio frequency devices in support of several government customers.
2007 : 2013
SAIC
Senior RF Systems Engineer
2001 : 2006
Northrop Grumman Corporation
Engineer
Company:
MedCrypt
Years of Experience:
22
Skills
Analysis, DoD, Earned Value Management, Embedded Systems, Engineering Management, Information Assurance, Integration, Radar, Radio Frequency (RF), Requirements Management, RF, Simulations, System Architecture, System Design, Systems Engineering, Testing
About
Joined Medcrypt a year ago now. Super excited to work with all of the talented folks here. Very happy to be able to continue to achieve the mission of providing better, safer and more secure medical devices to the community of patients and HCPs who need better tools faster to achieve better health outcomes.
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