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FDA cybersecurity maturity
78Overall readiness score
Former FDA reviewer
Evidence mapped to the reviewer concern before submission.
Postmarket plan needs traceable vulnerability-response evidence.
One platform · one connected record
The same MSI view follows the work from the first maturity signal through assessment, evidence mapping, gap resolution, and a defensible submission-ready outcome.
01 · Measure
MSI turns the state of your submission evidence into a single readiness signal, so the team can see where review risk is concentrated.
FDA cybersecurity maturity
78Overall readiness score
02 · Assess
The platform breaks readiness into the domains FDA will evaluate, with the strongest and weakest areas visible in one report.
Maturity assessment
03 · Connect
Architecture, threat models, SBOM, testing, and postmarket plans stay connected instead of living in separate documents and tools.
Architecture
Mapped to submission evidence
Threat model
Mapped to submission evidence
SBOM
Mapped to submission evidence
Testing
Mapped to submission evidence
Postmarket
Mapped to submission evidence
04 · Resolve
Teams move from a finding to the missing evidence, owner, and next action—with former FDA reviewer context available in the same workflow.
Prioritized workstream
05 · Prove
When the evidence is complete and mapped, the same platform view becomes a defensible record of cybersecurity compliance and product security.
MSI readiness outcome
Cybersecurity evidence mapped, gaps resolved, and the product prepared for review and ongoing security.
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.
