Client Profile
The client is a medical device manufacturer developing network-connected, software-driven medical devices deployed across hospitals and clinical environments in the US and APAC regions. The devices integrate embedded Linux systems, cloud-connected services, and remote monitoring capabilities to support critical patient care workflows.
Following rapid product adoption, increased device connectivity, and evolving FDA cybersecurity requirements, the client sought a comprehensive medical device cybersecurity assessment to ensure device safety, regulatory readiness, and resilience against cyber threats throughout the product lifecycle.
Key Security Concerns Included
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Insecure device configurations exposing attack surfaces across network interfaces
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Limited visibility into device health, logging, and postmarket cybersecurity events
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Absence of a formal Secure Product Development Framework (SPDF) aligned with FDA guidance
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Weak key management and credential protection within embedded systems
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Exposure to unauthorized access, data manipulation, and denial-of-service scenarios
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Gaps in cybersecurity documentation required for FDA premarket submissions
Solution
COE Security implemented a customized Medical Device Cybersecurity Assessment, combining regulatory-aligned engineering practices with real-world security testing:
Device Architecture & Configuration Review
Audited embedded software, operating systems, communication interfaces, and backend integrations for security misconfigurations.
Threat Modeling & Risk Assessment
Performed FDA-aligned threat modeling to identify cybersecurity risks impacting patient safety and device effectiveness.
Secure Key & Credential Management Review
Assessed cryptographic key storage, authentication mechanisms, and access controls within device firmware and cloud services.
Static & Dynamic Security Testing
Conducted code analysis and runtime testing to uncover vulnerabilities in device software and communication flows.
Penetration Testing & Attack Simulation
Simulated real-world cyberattacks including unauthorized access, data exfiltration, and service disruption scenarios.
Resilient Devices, Continuous Patient Safety
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Hardened device configurations with encrypted communications and secure authentication
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Identified and remediated critical API exposure allowing unauthorized device interaction
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Implemented centralized logging, telemetry, and device health monitoring
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Secured backup and recovery mechanisms for safety-critical device functions
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Reduced device downtime through redundancy and fail-safe architecture
Governance, Strategy & Regulatory Maturity
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Established a Secure Product Development Framework (SPDF) aligned with FDA cybersecurity guidance
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Developed cybersecurity risk management processes integrated with ISO 14971 safety controls
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Created incident response and vulnerability disclosure playbooks for postmarket compliance
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Defined software update, patching, and change control mechanisms
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Advised on secure device lifecycle management and postmarket surveillance strategy
Medical Device Cybersecurity Services Delivered
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Medical Device Cybersecurity Gap Analysis
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Threat Modeling & Cybersecurity Risk Assessment
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Secure Product Development Framework (SPDF) Implementation
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Static Code Analysis & Software Security Review
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Penetration Testing for Connected Medical Devices
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SBOM Generation & Vulnerability Monitoring
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FDA Premarket Cybersecurity Documentation
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Postmarket Cybersecurity Monitoring & Support
Implementation Details
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Assessed embedded Linux-based medical devices and cloud-connected components
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Performed threat modeling aligned with FDA, IEC 62304, and ISO 14971
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Hardened cryptographic key storage and authentication mechanisms
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Validated device resilience through simulated cyberattack scenarios
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Delivered a comprehensive cybersecurity assessment report with prioritized remediation roadmap
Results Achieved
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Achieved FDA-ready cybersecurity documentation supporting premarket submission
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Identified and mitigated 15+ critical and high-risk cybersecurity issues
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Improved device security posture without impacting performance or usability
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Reduced risk of unauthorized access and service disruption
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Increased stakeholder confidence in device safety, security, and regulatory readiness
Client Testimonial
“COE Security brought clarity and confidence to our medical device cybersecurity strategy. Their deep understanding of FDA expectations and hands-on technical expertise helped us secure our devices while accelerating our regulatory journey.”