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Cybersecurity
Safeguarding Innovation in Connected Devices
Cybersecurity in healthcare is vital to protecting patient safety, safeguarding confidential data, and preventing potentially life-threatening system breaches. In medical device development, healthcare web and mobile applications, and all forms of connectivity, strong security measures are fundamental to patient trust, regulatory compliance, and system resilience.
Regulatory Compliance Services
Solutions We Offer
Embedded Device Security
Cloud & Connectivity Security
Product Threat Modeling & Risk Assessment
SBOM Analysis & Vulnerability Detection
Architecture and design aligned with FDA guidance on cybersecurity, ANSI/AAMI SW96, and IEC 62304
Data privacy-by-design and security-by-design principles for HIPAA compliance
Documentation for regulatory submissions and audits
Firmware protection, secure boot, and hardware root of trust
Protection of wireless interfaces (e.g., BLE, Wi-Fi, NFC)
Secure over-the-air firmware updates for post-market vulnerability mitigation
Secure architecture for cloud-hosted medical platforms (Azure/AWS/GCP)
API security, endpoint hardening, and secure communication protocols
Monitoring and logging strategies to support real-time event tracking, and issue detection
Identification of potential attack surfaces using methods like STRIDE
Risk analysis aligned with IEC 81001-5-1, ISO 14971, utilizing CVSS and cybersecurity FMEA
Identify, implement, and verify controls for threat mitigations
Generation and management of Software Bill of Materials (SBOM) for transparency and traceability
Perform static and dynamic code analysis, vulnerability scans, and penetration testing
Support implementation of post-market cybersecurity surveillance for FDA compliance
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