Pricing
Per submission - not per year. For teams filing a 510(k) once or twice, where a $65K consultant and a $35K/yr platform are both the wrong shape.
Readiness check
- Scored gap report against FDA's current cybersecurity guidance
- Your eSTAR technical-screening risk, plainly stated
Draft pack
- Complete §524B draft package in minutes
- Threat model · risk assessment · SBOM · postmarket plan · review checklist
- Verified AI polish (local or frontier models) included
- One price per submission - regenerate as often as you need until clearance
- Automation only at this tier: no reviewer, no signature
Pack + expert review
- Everything in Draft pack
- Named, independent regulatory & security reviewers - vetted, and independent of the work they are checking
- Private workspace with your reviewer - messages and file exchange
- Draft fee deducted; you never pay for the same work twice
- A fixed price where consultant authoring plus deficiency documentation is hourly - and a redesign does not re-bill
- One deficiency-response round on the cybersecurity section included
Same starting point: describe your device, get the draft, then add expert review in one click from the results page. What you paid for the draft comes off this price, and the exact figure is shown before you pay.
Local / on-prem runner coming soon
- The full engine running entirely inside your network
- Nothing - not even metadata - leaves your environment
- Local AI polish with your own models
- For trust-sensitive and enterprise programs
After clearance, the plan has to stay true
Your postmarket cybersecurity plan and your SBOM are not a one-time filing. New vulnerabilities are published against software you have already shipped. Your SBOM is the list of what to check them against. A plan that was accurate on the day you were cleared goes stale within months, and keeping it current is work somebody has to own.
An upkeep subscription is planned and not yet available. The intent is roughly $1,500-$5,000 a year, by how much software is in the device. It would monitor the public vulnerability feeds against your SBOM, and revise the plan when your software or your disclosure process changes. If you would want it, tell us and we will come back to you when it exists.