Pricing
Per submission — not per year. Built for the ~2,000 companies that file a 510(k) once and are unserved by $65K consultants and $35K/yr enterprise platforms.
Readiness check
Free
self-serve, 10 minutes
- Scored gap report against FDA's current cybersecurity guidance
- Your eSTAR technical-screening risk, plainly stated
Draft pack
$2,500–$7,500
per submission — guided draft pack, by device complexity
- Complete §524B draft package in minutes
- Threat model · risk assessment · SBOM · postmarket plan · review checklist
- Verified AI polish (local or frontier models) included
- Unlimited re-runs while you iterate on the same device
Pack + expert review
$18,000–$30,000
all-in — draft + independent RA/security sign-off, by device complexity
- Everything in Draft pack
- Named, independent regulatory & security reviewers
- Private workspace with your reviewer — messages and file exchange
- Draft fee deducted; you never pay for the same work twice
- Still 3–8× below the consultant ladder
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
Premium
annual license
- 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
Also included in every paid tier
Postmarket plan upkeep subscription available ($1,500–$5,000/yr) — the postmarket cybersecurity plan is a statutory living document; we keep it and your SBOM current after clearance.