100% FDA approval rate guaranteed: our platform finds the gaps in your cybersecurity submission and our former FDA reviewers check it before you file.
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Cleared for FDA review
Every section, evidence-backed
Reviewed by former FDA reviewers before you file.
From first assessment to filed submission
Score your maturity in about thirty minutes, see which eSTAR sections still owe evidence, get reviewer-style findings cited to the requirement, and close them before you file.
01 · Assess
About thirty minutes per device, graded across the five practice areas FDA evaluates. You get a level out of five for each, so a weakness has a name and a number before anyone has to defend it.
Maturity Assessment
~30 min per device
Overall maturity
02 · Benchmark
Your package is scored against the structure the FDA will actually review it in. Each category comes back fulfilled, partial, or not fulfilled, so you can see which sections are ready to file and which still owe evidence.
FDA eSTAR Readiness
8 of 12 categories addressed
submission-ready
03 · Audit
Regulatory Audit reads your threat model, risk assessment, and SBOM as one body of evidence and returns reviewer-style findings, each ranked Critical, Major, or Minor with the requirement it cites attached.
Regulatory Audit
Ranked by severity, cited to requirement
findings by severity
04 · Resolve
Every finding stays open until it is closed or dismissed with a reason, so a package that has been worked through can be told apart from one that has only been scanned. Former FDA reviewers help triage what is worth your time.
Prioritized workstream
Open until closed or dismissed with a reason
The critical two, first.
Findings carry an owner, the evidence they need, and reviewer context in the same workflow.
05 · Prove
When the evidence is complete and mapped, the same platform view becomes a defensible record of cybersecurity compliance, and the annual re-run Section 524B requires is a re-scan rather than a rebuild.
Readiness outcome
Evidence mapped
Every finding traced to its requirement
Gaps closed
Or dismissed on the record, with a reason
Section 524B
The annual re-run is a re-scan, not a rebuild
Bring former FDA reviewer context to the response, connect each concern to supporting evidence, and keep the remediation path visible to the whole team.
Review your situationLessons from the first wave of FDA inspections under the new quality framework.
Mandatory vulnerability reporting begins September 11, 2026.
Regulators now use AI to catch inconsistencies in submissions.