Device Readiness Assessment
Identify missing documentation, inconsistencies, and evidence gaps before regulators do.
Scenario
A Class II SaMD company is weeks away from filing a 510(k) through eSTAR. The package is nearly complete, but internal reviews keep missing small omissions, inconsistencies, and evidence gaps. Leadership is concerned that preventable issues could trigger Refuse-to-Accept review problems or an FDA Additional Information request, delaying clearance and burning cash.
Objective
Use Tyto Device Readiness workflow to review the draft eSTAR package and supporting attachments for completeness, consistency, and submission readiness before filing.
How it works
Tyto ingests the draft eSTAR and linked documents, maps claims to supporting evidence, and analyzes the package section by section. It identifies missing content, conflicting statements, traceability gaps, and other deficiencies that can slow FDA review.
Output
Your team receives a prioritized, section-by-section gap report with findings, citations, and recommended fixes. Instead of relying on repeated manual review cycles, you can resolve issues before submission and file with greater confidence.
Business impact
Tyto helps regulatory teams reduce avoidable omissions, tighten submission quality, and lower the risk of preventable review delays.
Best for
Medical device companies preparing a 510(k) eSTAR submission for a Class II device, especially when the package is close to filing and the cost of delay is high.
Example of Report Output
Level of Completion
Build your compliance path with Tyto.
who need faster, defensible reviews of DHFs and submissions.