Simple, usage-based pricing

Simple, transparent pricing for MedTech teams.

FDA 21 CFR Part 11IEC 62304eSTAR ReadyHMAC-Sealed

What's a token-unit? One unit equals one AWS Bedrock inference call through the Omnis pipeline — an AI document analysis, a semantic regulatory match, or a compliance summary. Unused units don't roll over; overage is billed at the next tier's rate.

Starter

$499/ month
500 token-units / mo

For small MedTech teams shipping their first regulated device.

Ideal up to ~500 Bedrock inference calls per month.

  • Automated 21 CFR Part 11 Audits
  • Unlimited CLI Ingestions (< 200ms)
  • AWS Bedrock Document Intelligence
  • Real-time Traceability Matrix
  • Role-Based Access Control (QA, Dev, Viewer)
  • HMAC-Signed Evidence Ledger
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Most Popular

Growth

$899/ month
1,200 token-units / mo

For active teams running multiple concurrent device pipelines.

1,200 units at $0.75/unit — vs $1,000+ raw cost. Save 10%.

  • Everything in Starter
  • Unlimited CLI Ingestions (< 200ms)
  • Priority AWS Bedrock AI pipeline
  • Advanced Traceability & Diff Reports
  • Up to 10 team members
  • eSTAR PDF Export — Audit-Ready Package
Start Growing

Scale

$1,399/ month
2,500 token-units / mo

For enterprise MedTech teams with high-volume submission cycles.

2,500 units for $1,399 — upgrading saves ~$500 vs Growth + overage.

  • Everything in Growth
  • Unlimited CLI Ingestions (< 200ms)
  • Dedicated Bedrock inference budget
  • Multi-org Dashboard & Rollup Reports
  • Unlimited team members + SSO
  • SLA Support — Custom Regulatory Mapping
Scale Up

30-day free trial · Cancel anytime · No setup fees

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Understand what you're getting

FeatureStarterGrowthScale
Monthly token-units5001,2002,500
Cost per token-unit$1.00$0.75$0.56
Overage rate (next tier)$0.75$0.56Contact us
Team membersUp to 3Up to 10Unlimited
eSTAR PDF exportYesYesYes
HMAC-signed evidence ledgerYesYesYes
SSO / SAMLYes
SLA supportEmailPriority

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