How 510sec works

1 · You describe the device

Components, how they connect, and the third-party software inside. No source code, no repository access. Roughly 15–25 minutes for a first pass.

A connected ECG patch, for example: firmware, a mobile app, a cloud ingest API, an analysis service and a clinician portal — five components and the links between them.

2 · The rule engine walks every component and connection

A deterministic checklist in code — not a chatbot — applies STRIDE to each component and each dataflow. Same input, same output, every time.

That determinism is what makes the tool validatable under FDA's Computer Software Assurance guidance. Optional AI polish only rewords prose, and every rewrite is checked against the original before it is accepted.

3 · You get the documentation package in seconds

Threat model, cybersecurity risk assessment, SBOM with vulnerability and end-of-support findings, postmarket plan, and a review checklist mapped to the FDA guidance section by section.

Exports as Markdown, DOCX, ZIP and machine-readable CycloneDX JSON.

4 · Gaps are declared, never invented

Anything the tool cannot honestly produce — penetration-test evidence, labeling, operating metrics — is written into the pack as a declared gap with an explanation of what you must supply.

This is the part reviewers tell us they value most: the pack tells your regulatory expert exactly where to spend their hours.

5 · A qualified human reviews and signs

The draft goes to your regulatory and security reviewer, exactly as a consultant's draft would. We replace the authoring cost — not the accountability.

Typical effect: hours of expert review instead of weeks of expert authoring.

Want to see real output?

Ask us for a walkthrough of a complete generated pack — we will show you the declared gaps too, not just the finished sections.