AI-Driven Compliance and Security partner for medical devices and healthcare

Rigorous regulatory documentation audits, FDA/NIST cybersecurity dossiers, and complete HIPAA compliance support across systems and governance.

Try Tyto Audit for Free

Device Readiness Audit

Analyzes your Design History File and provides a clear picture of 510(k) and Technical File readiness—highlighting missing documentation, design-control gaps, and specific remediation steps.
eSTAR/Technical File Assembly & Audit

Converts your DHF into a fully populated FDA eSTAR or Technical File using a data-centric approach: Tyto extracts evidence, maps it to structured fields, and drafts missing narratives like the 510(k) Summary.
HIPAA as a Service

We deploy pre-made, HIPAA-compliant infrastructure-as-code runtime in your cloud account, plus safeguards, policies, docs, and training to unblock deals.
Cybersecurity Compliance Dossier

Creates the complete cybersecurity section for your FDA eSTAR and EU Technical File—every required artifact, mapped, consistent, and traceable.

Designed to Deliver Clarity and Trust

Stronger documentation

Fewer surprises from regulators

Better use of expert time

Faster go-to-market

Cut months of manual preparation, review and assembly work.

Why do you need Tyto?

Instead of months of spreadsheet tracking and copy-paste, your team works from a clear, AI-generated roadmap to “ready to file.” Tyto reads your existing DHF and submissions, reconstructs the regulatory story, and shows you exactly: