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.
Cybersecurity
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.
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.
SBOM & SOUP Analysis
Our SBOM & SOUP analysis ensures full visibility into your device’s software supply chain, identifying vulnerabilities before they become risks. We help MedTech startups and device developers validate open-source and third-party components for compliance and security. With our actionable insights, you can accelerate development while meeting the highest regulatory and cybersecurity standards.
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.
Post Market Surveillance & 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.
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.