Naomi Schwartz
About Naomi Schwartz
Naomi Schwartz is the VP of Services at Medcrypt, with extensive experience in medical device regulation and cybersecurity, particularly in diabetes devices.
Naomi Schwartz - Profile
Naomi Schwartz is the Vice President of Services at Medcrypt. She has more than six years of experience at the FDA's Center for Devices and Radiological Health. In her role, she engages with various medical device manufacturers, offering solutions to improve their quality systems and integrate security considerations throughout the device development lifecycle. Naomi's work extends into evaluating software, cybersecurity, and interoperability of medical devices.
Naomi Schwartz's Expertise in Medical Device Regulation
Naomi Schwartz is an expert in the regulation of medical devices, specifically in the diabetes diagnostic and therapeutic field. Her extensive background includes helping develop new class II pathways to enhance the regulatory science for interoperable diabetes devices. Naomi initially joined the FDA as a medical device regulator in 2016, focusing on cybersecurity review. Her expertise has been pivotal in advancing the dependable system design for medical devices.
Naomi Schwartz's Contributions to Cybersecurity and Interoperability
A significant aspect of Naomi Schwartz's work involves dependable system design by evaluating medical device software, cybersecurity, and interoperability. Her efforts at the FDA included assessing the cybersecurity of medical devices to ensure they meet safety and regulatory standards. Naomi has been instrumental in creating pathways that improve regulatory science, particularly for interoperable diabetes devices, ensuring they are safe and effective for public use.
Naomi Schwartz's Role at Medcrypt
At Medcrypt, Naomi Schwartz supports a diverse range of medical device manufacturers by improving their quality systems and embedding security thinking throughout all phases of device development. She focuses on feeding back data from postmarket activities into premarket decision-making and designs, crucial for maintaining business reputation and stakeholder trust. Her role is central to helping MDMs navigate the complexities of medical device regulations and cybersecurity.
Naomi Schwartz's Educational Background
Naomi Schwartz holds a Master's degree in Electrical and Computer Engineering from Carnegie Mellon University. This advanced education underpins her expertise in the technical aspects of medical device regulation and cybersecurity. Additionally, Naomi is recognized as a Certified Quality Auditor, which further validates her capabilities in ensuring the quality and reliability of medical devices.