Threat Modeling & Risk Assessment
We conduct formal threat modeling and cybersecurity risk assessments early in development, using frameworks such as STRIDE to identify potential vulnerabilities across the system. We map risks at each interface, including device firmware, cloud APIs, mobile apps, and data storage, and implement mitigation strategies aligned with ISO 14971, AAMI TIR57, and FDA guidance. This approach ensures traceable, risk based security that supports both design quality and regulatory expectations.
Cybersecurity
Secure Architecture & Design
Our engineers develop robust system architectures that prioritize security without compromising usability or performance. We incorporate security into embedded platforms, web and mobile environments, and SaMD products, applying principles like secure boot, encrypted data storage, and hardened authentication. We also evaluate and manage SOUP (Software of Unknown Provenance) to ensure third party libraries are safely integrated and documented.
Regulatory Compliance
We support clients through FDA, CE, and global cybersecurity compliance processes. Whether your product is a networked device or a standalone SaMD, we help prepare cybersecurity documentation including Cybersecurity Risk Assessments, Cybersecurity Management Plans, labeling content, and Software Bills of Materials (SBOMs), all aligned with FDA premarket guidance and IMDRF principles.
Secure Software Development
Security is baked into our development workflows for embedded firmware, mobile applications, and SaMD platforms. We apply secure coding practices, code scanning, SOUP management, and continuous integration with security controls to ensure that every line of code meets quality and compliance standards from day one.
Penetration Testing & Vulnerability Scanning
We conduct penetration testing, fuzzing, and automated vulnerability scanning for devices and SaMD platforms. These tests help identify and eliminate exploitable vulnerabilities before release, supporting both risk reduction and submission readiness.
Cloud & Mobile Security
We build HIPAA compliant cloud systems and mobile apps with strong encryption, user role management, and secure API integrations. For SaMD and connected devices, we ensure end to end data security across BLE, WiFi, and cellular connections, with robust cloud security architecture and monitoring in place.
Cybersecurity Remediation
If vulnerabilities are discovered late in development or post launch, we support fast, compliant remediation. Our team helps assess root causes, redesign insecure components, and update security documentation, including SBOMs, CAPA records, and revised threat models. Whether you are facing an audit finding, customer concern, or FDA inquiry, we help you respond swiftly, mitigate impact, and maintain product integrity.
Post Market Monitoring & Incident Response
We help establish and maintain cybersecurity post market processes, including vulnerability disclosure protocols, patch strategies, and SBOM versioning updates. Our plans align with FDA post market guidance and ensure your SaMD or device product remains secure and compliant after launch.
Post Market Monitoring & Incident Response
We help establish and maintain cybersecurity post market processes, including vulnerability disclosure protocols, patch strategies, and SBOM versioning updates. Our plans align with FDA post market guidance and ensure your SaMD or device product remains secure and compliant after launch.