Full-shop cybersecurity for regulated medical devices
Threat modeling, cybersecurity risk assessment, and design gap assessment aligned with FDA cybersecurity guidance, international standards, and engineering best practices. This work establishes the foundation for secure product development, cybersecurity testing, and regulatory submissions throughout the product lifecycle.
The Cybersecurity Risk Management Methodology establishes the process, methodology, and traceability used to manage cybersecurity risk throughout the product lifecycle. We develop or update an organization's cybersecurity risk management process to integrate cybersecurity engineering activities with quality management processes, design controls, and applicable regulatory requirements.
The Cybersecurity Design Gap Assessment compares a device's architecture, design documentation, and implemented or planned security controls against its threat model, cybersecurity requirements, applicable standards, and regulatory expectations. The assessment identifies where the current design falls short and outlines what the team should consider changing to strengthen the design.
Threat modeling and cybersecurity risk assessment identify, analyze, and prioritize cybersecurity risks across the product architecture. Beginning with a structured decomposition of the system into assets, trust boundaries, interfaces, and data flows, we identify potential threats, evaluate attack paths, and assess cybersecurity risk using established methodologies.
The resulting cybersecurity risk assessment provides traceability from identified threats through risk evaluation, security controls, verification activities, and residual risk documentation. These work products support secure product development, cybersecurity testing, and FDA cybersecurity documentation.
Secure by Design translates cybersecurity requirements into implementable system architectures and software designs. We work with engineering teams to develop security controls that satisfy regulatory expectations while respecting the technical constraints of existing hardware, firmware, software, and deployment environments.
Cybersecure Design Support develops the cybersecurity architecture and detailed design required to implement security controls throughout the product. We work from system requirements and existing architecture to define security mechanisms that address authentication, authorization, cryptography, confidentiality, integrity, logging, resiliency, and secure software updates.
Cybersecure Implementation supports development teams during implementation of security-critical functionality. We implement or review security-sensitive code, evaluate cryptographic implementations, and verify secure coding practices through static and dynamic analysis.
Cybersecurity Testing provides objective evidence that implemented security controls perform as intended. Testing activities evaluate products under realistic attack conditions and generate the technical evidence required to support cybersecurity risk management and regulatory submissions.
Penetration and Vulnerability Testing evaluates the security of deployed systems through structured technical testing. Testing activities include attack surface analysis, vulnerability assessment, penetration testing, binary analysis, fuzz testing, and validation of implemented security controls.
Software Composition Analysis identifies third-party and open-source software components, generates Software Bills of Materials (SBOMs), and evaluates known vulnerabilities affecting those components. The resulting SBOM supports regulatory submissions, vulnerability management, and lifecycle maintenance.
Cybersecurity Requirements Verification provides objective evidence that implemented cybersecurity requirements have been satisfied. Verification activities establish traceability between design inputs, implementation, testing, and regulatory documentation.
Regulatory Support helps manufacturers prepare cybersecurity documentation for FDA premarket submissions and respond to regulatory questions throughout the review process. We focus on the technical documentation supporting cybersecurity rather than the broader regulatory submission itself.
We assemble your cybersecurity submission package — threat model, risk assessment, SBOM, and testing evidence — into a complete, traceable eSTAR-ready package built to anticipate the FDA's most common cybersecurity questions.
When the FDA comes back with cybersecurity questions or a deficiency letter, we help you understand what's being asked, close the gap behind the question, and draft a response designed to give the FDA what it needs to close the question.
Before you submit, we review your existing cybersecurity documentation against current FDA premarket cybersecurity guidance and flag documentation gaps that commonly draw FDA cybersecurity review questions — giving you a clear, prioritized remediation plan while there's still time to act on it.