Cybersecurity Dossier for FDA Submission
Turn software evidence into a submission-ready cybersecurity package
Scenario
A medical device company is preparing a software-containing device for FDA submission, but lacks a complete cybersecurity dossier. The team has software documentation, architecture materials, and some test evidence, but still needs to produce a defensible threat model, cybersecurity management plan, security controls documentation, and supporting submission content. Internal teams risk spending weeks manually pulling these pieces together.
Objective
Use Tyto CyberPack to analyze existing software documentation, generate the core cybersecurity dossier required for FDA submission, produce the required testing plan, and assemble the final package for filing.
How it works
Tyto reviews the company’s software and system documentation using a data-centric approach, extracting architectural, functional, and risk-relevant evidence already present in the documents. From that evidence, it generates the core cybersecurity package — including the threat model, cybersecurity management plan, security controls documentation, and other FDA-aligned submission artifacts — and produces a targeted list of required penetration tests.
After test results are uploaded, Tyto incorporates them into the evidence structure and ties the full package together into a coherent, submission-ready cybersecurity file set.
Each step is completed in under an hour, so teams can move through dossier generation in hours instead of waiting weeks for sequential contractor deliverables.
Output
Your team receives a structured cybersecurity dossier with generated core documents, identified gaps, a defined pen-test and vulnerability-testing list, and a finalized package aligned for FDA submission.
Business impact
Tyto helps teams avoid weeks of manual cybersecurity document drafting, reduce fragmented work across RA, software, and security teams, and accelerate the preparation of a complete FDA-ready package. Instead of building the dossier from scratch, teams move from existing software evidence to a submission-ready cybersecurity package with far less manual effort.
Best for
Medical device companies preparing an FDA submission for a SaMD or software-containing device need to rapidly generate and complete the cybersecurity documentation expected in the submission package.
Tyto CyberPack Output
Build your compliance path with Tyto.
who need faster, defensible reviews of DHFs and submissions.