Rigorous regulatory documentation audits, FDA/NIST cybersecurity dossiers, and complete HIPAA compliance support across systems and governance.
Analyzes your Design History File to provide a clear assessment of 510(k) and EU MDR Technical File readiness—identifying missing documentation, design control gaps, and required remediation steps.
Converts your DHF into a fully populated FDA eSTAR or EU MDR Technical File. Through a data-centric approach, Tyto extracts supporting evidence, maps it to structured regulatory fields, and automatically drafts missing narratives such as the 510(k) Summary.
We deploy pre-made, HIPAA-compliant infrastructure-as-code runtime in your cloud account, plus safeguards, policies, docs, and training to unblock deals.
Creates the complete cybersecurity section for your FDA eSTAR and EU Technical File—every required artifact, mapped, consistent, and traceable.
Evidence mapped to relevant FDA guidances and ISO/IEC standards.
Catch gaps and inconsistencies before FDA or Notified Body does.
Let AI handle the grunt work so your specialists focus on judgment and strategy
Cut Months from Preparing, Reviewing, and Assembling Regulatory Documentation and Submissions.
Instead of months spent tracking spreadsheets and copying data between documents, your team follows a clear, AI-generated roadmap to a ready-to-file submission. Tyto analyzes your existing DHF and submissions, reconstructs the regulatory story, and shows you exactly:
who need faster, defensible reviews of DHFs and submissions
who want clarity on “how far are we from 510(k)” without drowning in documentation
who want to provide rapid services to their clients.
who want quick visibility into regulatory maturity during diligence.
who need faster, defensible reviews of DHFs and submissions.