FDA 510(k) Cybersecurity Remediation
Challenge
Cloud-hosted clinical platform approaching an FDA 510(k) submission with critical security and compliance gaps. A gap between the cybersecurity documentation an FDA submission requires and the state of the platform underneath it.
Approach
Ran a comprehensive security and compliance audit across cloud infrastructure, application security, and data governance. Identified and prioritized critical vulnerabilities. Led modernization of the legacy clinical portal to HIPAA-compliant, audit-ready architecture on current infrastructure.
Result
Cybersecurity remediation carried through to 510(k) submission. Audited submission security claims against the shipped product and reconciled the documentation to as-built behavior. Used production traffic to establish which interfaces were genuinely in use and retired the rest, reducing attack surface ahead of testing. Scoped and managed independent third-party penetration testing and drove findings to closure. Also delivered a substantial reduction in cloud infrastructure spend in the opening weeks of the engagement.
Work of this kind
This engagement is the sort of thing covered by FDA cybersecurity remediation. The full list is on the case studies index.
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