Regulators, including the U.S. Food & Drug Administration (FDA) and the European Union under MDR/IVDR, are embracing threat modeling as a recommended best practice to assure the appropriate reduction of cyber risks of medical devices.
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Threat modeling identifies & helps reduce potential security issues across risk types for makers and users; including patient safety risks.
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R&D teams need to incorporate security into their continuous design and engineering processes.
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Ensures that your team has the ability to identify threats and iterate on existing threat models that are generated.
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Allows security to be a part of the medical device development lifecycle.
Whether you want a virtual 3 hour self-driven course or in-person training with our world-class threat modelers, find confidence in your security strategy and related mitigations.
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At the end of the course, you'll build your own FDA-ready threat model using our templates, receiving personalized feedback, and then you'll be ready to start threat modeling your own devices!
Our team of former FDA analysts and medical device experts provides the best-qualified, credentialed, and experienced product security benefit-risk assessment in the world. Don’t go at this problem alone.
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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.
William, our VP of DevOps, has developed large, enterprise, cloud-native systems for over 20 years. As an early cloud adopter, he aggressively advocated for and led transitions and initial deployments to AWS since its inception in 2006. William co-founded Gamma Basics, a radiation oncology focused CAD software startup that was successfully sold to Varian Medical Systems in 2013. William holds a BS in Computer Science from The College of New Jersey.
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.
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Get your secure medical devices to market on or even ahead of schedule, with peace of mind.
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