No manufacturer fails an FDA cybersecurity audit for having vulnerabilities. Every device has them. Manufacturers fail because they can't show what they did about them: no documented process, no evidence a decision was made, no trail from finding to disposition. The audit tests your records, not your intentions.
The expectations are written down. The 2016 postmarket guidance and the 2023 premarket guidance, refreshed in 2025, describe cybersecurity as a continuous obligation across the device lifecycle. In an inspection that translates to three requests: show me your process, show me that it ran, and show me the rationale behind each decision it produced. Vague risk acceptance and missing records are what turn into findings, and findings are what turn into delays and market-access problems.
And the scope runs wider than most teams expect. Premarket files get revisited postmarket. A claim you made about patch timelines in a submission becomes an inspection question two years later, asked against your actual patch history. What you wrote and what you did have to match.
Most programs I've reviewed don't lack activity. They lack coherence. Scanner output lives in one tool. Penetration test results live in a PDF from eighteen months ago. The SBOM was generated for the submission and never touched again. Triage decisions live in a spreadsheet, or worse, in the memory of an engineer who left.
Each artifact existed. The story connecting them doesn't. So when an auditor asks how a specific vulnerability was evaluated and resolved, the answer becomes an archaeology project conducted under deadline. That reconstruction, not the vulnerability itself, is where audits go wrong.
The pre-audit scramble is the tell. If evidence has to be assembled, you didn't have a process. You had a project.
ELTON's answer is structural: one platform holding testing results, SBOM monitoring, static and dynamic analysis, and CVE feeds, all tied to the device's architecture. Every vulnerability carries its discovery method, its context-scored rating, its disposition, and the evidence behind it. Fixed or defensibly not fixed, the rationale is recorded either way. And it holds across the portfolio, including the legacy releases auditors love to ask about, not just the product you submitted last quarter.
The no-fix records matter most. In any real device, the majority of findings end in a justified no-fix, and those justifications are precisely what auditors probe. A one-line risk acceptance invites a finding. A recorded rationale, tied to architecture and backed by test evidence showing the path is blocked, closes the question before it opens.
Documentation then generates itself from that record. Living vulnerability reports, exploitability analyses, coordinated disclosure records, and the metrics FDA actually asks about: time-to-patch, percentage of vulnerabilities patched, testing cadence against your stated schedule. Nothing gets compiled for the audit, because it already exists as a byproduct of operating.
Periodic penetration testing appears in both the premarket and postmarket guidance, and the platform tracks that the cadence actually happened, on which releases, with what results. Risk assessments carry their scoring rationale. Dispositions carry their evidence. When the auditor's question comes, the answer predates it. That's the posture we've carried through more than 600 regulatory submissions, and it's why the audit week looks like any other week.
I think manufacturers who fear cybersecurity audits have the model backwards. The audit isn't the threat. It's the day someone finally asks to see the system you claimed to have. Run vulnerability management as an operation that produces records, and audit protection stops being something you prepare for. It becomes something you already did.
Start with one device. We build the twin from documentation your quality system already produces, run AI discovery remotely, and show you the graph: the handful to fix, and the evidence for everything else.
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Not for having vulnerabilities. Every device has them. Manufacturers fail because they cannot show what they did about them: no documented process, no evidence a decision was made, no trail from finding to disposition. The audit tests your records, not your intentions.
Three things: show me your process, show me that it ran, and show me the rationale behind each decision it produced. Vague risk acceptance and missing records are what turn into findings, and findings are what turn into delays and market-access problems.
Yes. Premarket files get revisited postmarket, so a claim you made about patch timelines in a submission becomes an inspection question two years later, asked against your actual patch history. What you wrote and what you did have to match.
Fragmentation. Scanner output in one tool, a penetration test PDF from eighteen months ago, an SBOM generated for the submission and never touched again, triage decisions in a spreadsheet or in the memory of an engineer who left. Each artifact existed. The story connecting them does not.
The scramble is the tell. If the evidence has to be assembled when the auditor arrives, you did not have a process, you had a project. That reconstruction under deadline, not the vulnerability itself, is where audits go wrong.