Cybersecurity leadership for Software as a Medical Device
Nutfield Security advises boards, investors, and executive teams on cybersecurity risk in SaMD and connected medical devices, from FDA premarket submissions through postmarket vulnerability management.
Services
Board Advisory & Governance
Independent, board-level cybersecurity oversight for medical device companies. We translate FDA Section 524B obligations, threat landscape, and program maturity into risk decisions the board can act on.
Transaction Due Diligence
Cybersecurity and regulatory diligence on SaMD and connected-device targets for investors and acquirers: product security posture, FDA submission readiness, SBOM and vulnerability debt, and the real cost of remediation.
FDA Premarket Cybersecurity
Section 524B readiness aligned to the FDA's 2023 premarket guidance: threat modeling, security architecture views, SBOM, security testing evidence, and submission documentation.
Postmarket Security
Coordinated vulnerability disclosure, secure update pipelines, and monitoring programs that meet FDA postmarket expectations across the device lifecycle.
Penetration Testing
Device, web application, and cloud penetration testing that produces submission-ready evidence, not just a findings list.
Security Architecture & DevSecOps
Secure-by-design architecture and automation for regulated products and the cloud environments behind them.
Why Nutfield Security
We work at the intersection of regulatory strategy and hands-on engineering. We have mapped every control in the current FDA cybersecurity guidance (see the full table) and we hold the certifications to back the engineering: CISSP, CCSP, GWAPT, and AWS security credentials.
Whether you need an independent director, a diligence partner, or a team to get a submission across the line, start the conversation.