The best services are worth sharing
Explore how Tyto helps companies accelerate regulatory compliance
Device Readiness Assessment
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 specific remediation steps.
Read case study
eSTAR/Technical File Assembly
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.
Read case study
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.
Read case study
Cybersecurity Compliance Dossier
Creates the complete cybersecurity section for your FDA eSTAR and EU MDR Technical File—every required artifact, mapped, consistent, and traceable.
Read case studyBuild your compliance path with Tyto.
who need faster, defensible reviews of DHFs and submissions.
