Tyto provides AI‑driven compliance solutions for medical device manufacturers, automating regulatory documentation, FDA/NIST cybersecurity dossiers, and HIPAA compliance. Its platform assesses Design History Files for 510(k) and EU MDR readiness, generates fully populated eSTAR or Technical Files, and delivers pre‑built HIPAA‑as‑a‑Service infrastructure to streamline audits and reduce regulator‑related surprises.
Funding
Funding not disclosed
Founders
Product
Problem
Medical device manufacturers must compile extensive regulatory documentation—Design History Files, FDA eSTAR submissions, EU MDR Technical Files, cybersecurity dossiers, and HIPAA compliance—often manually tracking spreadsheets and copying data, which leads to missed evidence, gaps, and delayed market entry.
Solution
Tyto offers an AI‑driven platform that ingests a company’s Design History File and automatically maps evidence to FDA, ISO/IEC, and EU MDR requirements. It generates a readiness assessment that highlights missing documentation and design‑control gaps, then assembles a complete eSTAR or Technical File, including cybersecurity sections and narrative summaries. The service also provides a pre‑configured, infrastructure‑as‑code HIPAA‑compliant environment for cloud deployments, complete with policies, safeguards, and training. By automating the grunt work of evidence extraction, mapping, and dossier creation, Tyto reduces the time needed to prepare, review, and submit regulatory packages, allowing experts to focus on strategic decisions and accelerating go‑to‑market timelines.
Target Audience
Tyto serves medical device companies and their regulatory, quality, and compliance teams that need faster, reliable preparation of FDA 510(k) and EU MDR submissions, as well as organizations requiring HIPAA‑compliant cloud infrastructure.
Features
- AI analysis of Design History Files to produce a detailed 510(k) and EU MDR readiness score with identified gaps
- Automated conversion of DHF data into fully populated FDA eSTAR or EU MDR Technical File, including auto‑drafted narratives such as the 510(k) Summary
- Generation of complete FDA/NIST cybersecurity dossiers with traceable artifacts mapped to regulatory fields
- Deployment of a turnkey HIPAA‑as‑a‑Service cloud environment using infrastructure‑as‑code, including policies, safeguards, documentation, and training
- Evidence mapping to relevant FDA guidances and ISO/IEC standards for stronger, auditable documentation
- Dashboard that visualizes regulatory maturity, missing items, and proximity to a defensible submission