With the increasing threat of cyberattacks, the FDA has heightened its focus on the cybersecurity resilience of medical devices. To avoid costly delays, eliminate rejections, and reduce post-market repercussions, your submission needs to demonstrate:
Our team of experts have a deep understanding of the FDA’s cybersecurity expectations. We work closely with you to ensure your submission is meticulously prepared to address every aspect of the guidance.
Naomi is a regulatory, compliance, and standards expert. She employs gap analyses, proposes mitigation strategies, and optimizes cybersecurity frameworks to address risk and uncertainty for device commercialization and to meet regulatory requirements and guidelines. Naomi has 20+ years of systems engineering experience.
Prior to Medcrypt, she was a premarket reviewer and consumer safety officer in CDRH for 6+ years, focusing on software, interoperability, and cybersecurity for connected diabetes devices. Her industry leadership and strategic direction include crafting standards and recommended practices for wireless diabetes device security, managing postmarket triage for cybersecurity vulnerability disclosure. She holds an MS in Electrical and Computer Engineering from Carnegie Mellon University and is a Certified Quality Auditor.
Seth has 10 years of medical device experience and provides strategic direction for cybersecurity products and services for the regulated device market.
Prior to Medcrypt, he spent 8 years at the FDA, architecting technology policy and laws that impact software-enabled medical devices, including the FDA’s medical device cybersecurity policies. His industry leadership and strategic direction extends to several high-profile industry frameworks including the Joint Security Plan (HSCC), MITRE’s Rubric for Applying CVSS to Medical Devices, and MDIC’s Playbook for Threat Modeling Medical Devices. He has authored several medical device cybersecurity papers and won several information security awards. He holds a PhD in Chemistry from Indiana University.
Jason is a Director of Cybersecurity Services at Medcrypt, specializing in FDA regulatory compliance for medical device cybersecurity. With extensive experience in 510(k) submissions, risk management, and cybersecurity strategy, he helps manufacturers navigate evolving regulatory landscapes. Jason has worked with leading medical device companies to implement robust security frameworks, ensuring compliance with FDA, EU MDR, and global cybersecurity standards. His expertise includes threat modeling, SBOM management, and incident response, making him a key resource for securing connected medical technologies.
AJ specializes in enterprise digital transformation, program development, continuous process improvement, and cybersecurity. He assesses organizational security and implements actionable transformation plans and services to achieve executive targets.
Prior to Medcrypt, he spent five years doing management consulting, providing comprehensive business transformation services to Fortune 500 clients in various industries, including Pharmaceuticals, Defense, Consumer Packaged Goods, and Medical Devices. He has a BS in Economics from Georgetown University, where he captained the 4x national champion Georgetown Sailing Team.
Nick is a cybersecurity expert with extensive experience in PKI, Risk Management, and regulatory compliance. At MedCrypt, he focuses on aligning security architectures and Quality Management Systems (QMS) with FDA and industry standards while ensuring solutions are practical and user-friendly. Previously, Nick led PKI initiatives at Cerner, managing enterprise cryptographic infrastructure and implementing automation to streamline security processes. His work emphasizes both enhancing security posture and delivering solutions that balance compliance with usability.
Ira is a expert cybersecurity professional with over 18 years experience. Having led organizations, projects, and initiatives in the federal government and private sector, he brings a multitude of medical device, IoT, regulatory, and cybersecurity operations expertise. Ira has held senior manager and director positions for a Top 40 medical device manufacturer. He has extensive knowledge of the best practices and challenges associated with risk management, vulnerability management, and incident response. He is also well versed in ensuring regulatory compliance with FDA, EU MDR, and other notified bodies.
Ira currently holds ISC2’s Certified Information Systems Security Professional (CISSP) and ISACA’s Certified Information Security Manager (CISM) and CompTIA’s Sec+ cybersecurity certifications. He also holds a M.S. in Cybersecurity.
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Don't leave your 510(k) submission to chance. With our support, you can navigate the complexities of the FDA's cybersecurity requirements and submit with confidence.
