Pricing built for the work, not for the seat.
Every Keenr report includes the full analysis. AI/ML devices receive the Predetermined Change Control Plan (PCCP) Intelligence layer, Foundation Model disclosure assessment, and Algorithm Change precedents at no additional cost.
- ✓ Executive Summary + ranked candidates with full scorecards
- ✓ Substantial Equivalence comparison (8 dimensions, eSTAR-aligned)
- ✓ FDA Best Practices scorecard (PASS / PARTIAL / CONCERN)
- ✓ Product Code Regulatory Trends
- ✓ Predicate citation lineage, three levels deep
- ✓ Cross-Code Landscape
- ✓ Safety surveillance (MAUDE + recall classification)
- ✓ Regulatory pathway decision
- ✓ Applicable FDA guidance, freshness-stamped
- ✓ eSTAR Optimization: 510(k) Summary narrative
- ✓ Score Composition appendix (every weight visible)
- ✓ AI/ML: PCCP Intelligence (66 cleared precedents)
- ✓ AI/ML: Foundation Model disclosure assessment
- ✓ AI/ML: Algorithm change precedents by category
Beta pricing. AI/ML reports will be $999 at general availability.
One full analysis · pay per report
- Best for: first-time founders and RA leads validating a single device
- ✓ Full 25+ page report (everything listed above)
- ✓ Re-download anytime from your account
- ✓ No expiry on the report itself
$433 per report · save $198 vs. singles
Three reports · pay once, run when ready
- Best for: teams with multiple device candidates or an evolving product roadmap
- ✓ Three full 25+ page reports
- ✓ Use any time, no expiry on credits
- ✓ Share within a single team
$399 per report · save $991 vs. singles
Ten reports · best price per report
- Best for: consulting practices and RA teams running multi-project portfolios
- ✓ Ten full 25+ page reports
- ✓ Use any time, no expiry on credits
- ✓ Share within a single team
By purchasing, you agree to the Terms of Use and Privacy Policy. Reports are non-refundable once generated.
Editable Word reports for consultants & RA teams
Subscription tier built for regulatory consultants and in-house RA teams who tailor reports for clients and submission packages. Same 25+ page analysis — delivered in editable .docx alongside PDF, ready to drop into your firm's template.
- ✓ Editable .docx export of the full report
- ✓ Portfolio dashboard across active devices
- ✓ Shared workspace for your team
- ✓ Volume pricing on report credits
- ✓ Priority support & consultation
- ✓ White-label / co-branding (Team tier)
Pilot code? Sign in here. · Enterprise or consulting white-label? info@keenr.ai
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