Security expertise for every stage of the device lifecycle
From first threat model to post-market surveillance — practical, regulator-ready cybersecurity support for medical device and health IT manufacturers.
Regulatory Compliance Consulting
Guidance on complex global cybersecurity regulations to ensure devices meet stringent security standards — FDA, EU MDR, HIPAA, IEC 81001-5-1, SW96, NMPA, and PMDA.
Explore this service →Security by Design Services
Cybersecurity embedded into every stage of the medical device lifecycle, ensuring resilient, compliant, and safe products from development through deployment.
Explore this service →Penetration Testing & Exploitability Validation
An ongoing, annually-renewed subscription — not a one-time scan — that continuously proves which findings are actually exploitable in your device's real operating context.
Explore this service →Post-Market Services
End-to-end SBOM monitoring, triage, risk assessment, security testing, and coordinated vulnerability disclosure management, run on your behalf against your cybersecurity management plan.
Explore this service →Executive Advisory & Fractional Leadership
Senior leadership support without full-time overhead — a fractional Head of Product Security for teams that need executive judgment now.
Explore this service →Choose the level of support your program needs
Essentials
For startups
Gap assessments, recommendations, and ready-to-use policy and document templates to get your security program off the ground.
Ask about this packageStandard
For FDA / MDR preparation
Risk management, threat modeling, document drafting, and security testing review to prepare a submission-ready package.
Ask about this packageComprehensive
For full lifecycle support
Everything in Standard, plus independent security testing and hands-on regulatory support through submission.
Ask about this packageNot sure which service fits?
Tell us about your device and timeline — we'll recommend the right starting point.