From radiology to cardiology, legacy to AI-enabled, we help you operationalize security across the full device lifecycle.
You manage 15+ device lines, some developed in-house, others via acquisitions. You need consistent, scalable cybersecurity processes across diverse teams and products at different lifecycle stages.
With 200+ successfully completed projects across 70+ clients, 100% of customers using Medcrypt's solutions and guidance have successfully achieved FDA approval.
Get a complimentary 30-minute portfolio security consultation with our experts.
Medical device cybersecurity is a hard problem to solve. Our Services team provides actionable roadmaps to facilitate product development, quality, and security frameworks to meet your pre- and post-market needs. No matter where you are in your process, we enhance your processes and agile methodologies to get to market, while optimizing your resources.
Need cybersecurity strategy helpOptimize your path to FDA cybersecurity readiness. We partner with you to ensure your devices can achieve the highest level of regulatory review, as well as develop cybersecurity programs that scale with you. Get your secure medical devices to market on or even ahead of schedule, with peace of mind.
Get immediate guidance to navigate your response process effectively.
Ensure your software ecosystem is protected and incorporate continuous security improvements into your design and engineering processes. We do a deep-dive investigation into your architecture, design, requirements, and implementation to create threat models that review current state, refine trust boundaries, identify requirements, and propose remediations, ensuring that your hardware, firmware, software, network communication, and data handling components to ensure you are protected now and in the future.
We assess your PKI and certificate management practices, perform gap analysis with industry best practices and regulatory guidance, and develop realistic and actionable mitigation strategies for medical devices.
Medcrypt's software and services secures your portfolio of connected devices with:
Every customer who needed help navigating cybersecurity documentation requirements for the FDA has had a 100% success rate.
Now, we’re offering a 100% guarantee for new customers: If you follow our guidance and your product meets cybersecurity expectations, we’ll support you through all FDA feedback - until your cybersecurity documentation is accepted.
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.
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.
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