Cybersecurity Gap Assessment
A focused review of existing cybersecurity artifacts against current FDA expectations and ANSI/AAMI SW96:2023, resulting in a prioritized gap list and practical remediation roadmap.
Medical device cybersecurity for submission-ready programs.
Quiet Vector assesses whether the cybersecurity artifact set FDA expects — SBOM, threat model, security risk management, architecture narrative, and SW96:2023 conformance — is ready for review, and names precisely what is missing or weak. So cybersecurity does not become the blocker. Where a gap is real and small — a broken trace, a weak threat analysis, a missing SBOM — remediation is available as a precisely scoped sprint, not a wholesale rebuild by default.
Request a consultationWhen this work is most valuable
This work matters most when cybersecurity evidence is thin, scattered across tools without a cohesive rationale for FDA review, or when submission timelines are near and cybersecurity is the known blocker. If Quiet Vector is not the right fit for the problem, that is said directly.
Cybersecurity evidence is assessed by the same engineer who reviews the design and risk file, so the security argument and the safety argument are evaluated against each other rather than in isolation.
How engagements run
Fixed-fee assessments, short remediation sprints, fractional advisory support, subcontract consulting. Remote or onsite.
Onsite support is available for critical milestones and audit preparation.
Scope, duration, and terms are confirmed in the intake call.
A short intake call clarifies scope. I tell you honestly whether I can help — and if I cannot, I say so.
— Wayne Larson, Principal Engineer, Quiet Vector LLC
Cybersecurity Services
FDA / SW96 Readiness Review
An independent readiness check of cybersecurity evidence for regulator-facing clarity, including traceability, rationale quality, and alignment to current FDA cybersecurity expectations.
Security Risk Management Remediation
Targeted remediation of security risk management artifacts and linked evidence, with a structured submission dossier deliverable (including SBOM, threat model, security risk management report, architecture narrative, and SW96:2023 conformance mapping).
Cybersecurity evidence is reviewed in the context of the wider design and risk file. See Design Assurance.
Standards & Domain Depth
ISO 13485 • ISO 14971 • IEC 62304 • IEC 62366 • IEC 81001-5-1 • IEC 62443 • ANSI/AAMI SW96:2023
Device coverage: Active implantables • Neurostimulators • Defibrillators • Implantable drug pumps • Programmers • Monitoring and patient data systems • SaMD • Combination products • Class II and Class III programs
Contact
- Location
- Minnesota, USA
- Phone
- 612-860-8507
- [email protected]
Concise details help prioritize response and scope.