Cybersecurity Threat Modeling

Secure-by-Design for Connected Medical Devices

As connected medical devices become more complex and interoperable, the need for strong, built-in cybersecurity protections is no longer optional—it’s essential. At PulseForward, we help teams identify, assess, and mitigate cybersecurity threats through structured threat modeling and industry-aligned practices. Our goal: to ensure your product is secure by design and compliant with regulatory expectations such as FDA premarket guidance, ISO/IEC 81001, and IMDRF cybersecurity frameworks.

Our Cybersecurity Services Include:

• Threat Modeling Workshops: Interactive sessions using STRIDE, DREAD, and attack trees to analyze system architecture and data flows.

• Security Risk Assessments: Identify vulnerabilities, potential exploits, and residual security risks across the device lifecycle.

• Data Flow & Trust Boundary Diagrams: Visual system mapping to detect weak points in communication, storage, and user interfaces.

• Mitigation Strategies & Control Mapping: Recommendations tied to NIST, FDA, and ISO standards for encryption, authentication, access control, and monitoring.

• Secure Development Lifecycle (SDL) Integration: Embedding cybersecurity best practices into your design, verification, and maintenance phases.

• SBOM Development & Management: Creation and ongoing support for Software Bills of Materials (SBOMs), required for compliance and transparency.

Why PulseForward?

Our team bridges deep medical device knowledge with advanced cybersecurity frameworks. Whether you're in early design or prepping for submission, we help you reduce risk exposure, protect patient data, and build regulator-ready documentation. Threat modeling isn’t a checkbox—it’s your first line of defense.