The cybersecurity section of your FDA submission, drafted with you.
Since 2023, FDA will not review a connected medical device until its cybersecurity documentation is complete and correct. 510sec turns a description of your device into a guided draft pack — threat model, security risk assessment, SBOM and postmarket plan — in minutes instead of weeks.
Start where you are
Free readiness check
For teams exploring the problem
- Twelve questions about your current documentation
- A scored gap report against the current FDA guidance
- No account, no card, no sales call
About 10 minutes
Guided draft pack
For teams ready to prepare documents
- A guided wizard walks you through device, components, connections and dependencies
- Every step explains what to enter, what we do with it, and what you get
- Generates the document set, with every gap declared rather than invented
1–3 hours of your input · generation takes minutes · $2,500–$5,000 per submission
Discovery call or demo
For teams unsure about fit or scope
- Walk through your device, the inputs needed and the outputs produced
- Confirm scope and pricing before you commit
- Or watch a guided demo first — no account required
30 minutes
Is this right for your device?
Best for small medical-device teams preparing a cybersecurity section for a 510(k), De Novo, or similar premarket submission. It is most useful when your team can provide a system description, components, interfaces, dependencies, existing controls, and whatever testing evidence you already have.
If you cannot yet describe your architecture, a discovery call is the better starting point — we will tell you honestly whether you are ready.
Comparing the three paths
| Path | Who it is for | What happens | Typical time |
|---|---|---|---|
| Readiness check | Exploring the problem | Answer a short questionnaire and receive your gaps | 10 minutes |
| Guided draft pack | Ready to prepare documents | Complete the wizard with support and receive a draft package | 1–3 hours of customer input; generation in minutes |
| Discovery / demo | Unsure about fit or scope | Talk through device, inputs, outputs and workflow | 30 minutes |
What the guided draft pack includes
We draft
- Threat model — per component and per interface, with the rule behind every threat
- Security risk assessment — exploitability × patient-harm severity, kept distinct from ISO 14971
- SBOM — CycloneDX 1.5 with FDA's support-status fields, plus vulnerability and end-of-support findings
- Postmarket cybersecurity plan — all nine required elements
- Review checklist — every claim traced to the guidance section behind it
You and your experts still own
- Penetration-test plan, report and independent testing evidence
- Vulnerability scan / test evidence, plus remediation and retest records
- Architecture diagrams and verification against the production system
- Cybersecurity labeling and MDS2
- Measures and metrics from real operating history
- Unresolved anomalies and defect evidence
- Qualified regulatory and cybersecurity review, and final risk acceptance
These are declared as gaps inside every pack, with an explanation of exactly what to supply. We would rather lose a sale than let a team believe their submission is finished when it is not.
Not sure which path fits?
Thirty minutes with us costs nothing and usually saves a week of guessing.
Request a 30-minute discovery call Watch the guided demo instead