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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 

Contact our Experts

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