PRICING · SIMPLE BY DESIGN

Pay per report. No seats. No subscription.

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.

WHAT'S IN EVERY REPORT 35+ page PDF · citation-linked

✓ Executive Summary + ranked candidates with full scorecards
✓ Readiness grade + FDA decision-time benchmark for comparable submissions
✓ Substantial Equivalence comparison (8 dimensions, eSTAR-aligned)
✓ FDA Best Practices scorecard (PASS / PARTIAL / CONCERN)
✓ Product Code Regulatory Trends — clearance volume, review times, key manufacturers
✓ Product Code Review — confirmed or disputed, with high-fit alternates
✓ Predicate citation lineage, three levels deep
✓ Cross-Code Landscape — adjacent codes where predicates hide
✓ Safety surveillance — code-level MAUDE signal + per-candidate deep dive with FDA links
✓ Regulatory pathway decision — Traditional / Special / Abbreviated 510(k), De Novo, Breakthrough, PMA
✓ De Novo precedents matched to novel-mechanism devices
✓ Pre-Submission Question Packet — draft Q-Sub questions + testing approach
✓ IDE determination when clinical data is likely needed
✓ Device-specific FDA guidance matched to your specialty panel, freshness-stamped
✓ eSTAR Optimization: 510(k) Summary narrative
✓ Score Composition appendix (every weight visible)
✓ AI/ML: PCCP Intelligence (80+ cleared precedents)
✓ AI/ML: Foundation Model disclosure assessment
✓ AI/ML: Algorithm change precedents by category
✓ AI/ML: Software taxonomy — SaMD/SiMD, locked vs adaptive

Single report

$499

Full analysis, AI/ML sections included.

One full analysis · pay per report

Best for: first-time founders and RA leads validating a single device
✓ Full 35+ page report (everything listed above)
✓ Re-download anytime from your account
✓ No expiry on the report itself

SAVE $198 3-report bundle

$1,299

$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 35+ page reports
✓ Use any time, no expiry on credits
✓ Share within a single team

SAVE $991 10-report bundle

$3,999

$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 35+ 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.

PARTNER PLANS · FOR CONSULTANTS & RA TEAMS

Editable Word reports, built for redlining

Plans for regulatory consultants and in-house RA teams who tailor reports for clients and submission packages. The core 35+ page analysis — ranked predicates, SE comparison, pathway, and 510(k) Summary — delivered in editable .docx alongside the full PDF, ready to redline straight into your firm's template.

✓ Editable .docx export of the full report
✓ Volume pricing on report credits
✓ Priority support & consultation

Coming to Partner plans: portfolio dashboard · shared team workspace · white-label co-branding — see the roadmap.

Email info@keenr.ai to set up a Partner plan

Have an access code? Sign in here. · Partner plans (white-label, teams): info@keenr.ai