Plans & Pricing

Audit-defensible AI for quality & regulatory professionals. Self-serve tiers from Free to Premium; Managed Service overlay available on Premium and Enterprise.

Not accepting new accounts at the moment. Existing customers can sign in to manage their plan. For enterprise, business or domain-knowledge support, contact on LinkedIn.
No account is needed for the QMSR Knowledge Pack, a one-time purchase of reference files (USD 129 per person).
Monthly
Annual Save 10%

Free

Get started

$0 /month
  • ~5 AI regulatory scans / month (a taste of the engine)
  • Regulatory radar — browse global alerts
  • Compliance Exposure diagnostic (view & 1 saved profile)
  • 3 audit simulations per month
  • QMSR readiness overview
  • Unlimited scans & custom alerts
  • Exposure→CAPA, PDF export, full gap analysis
Most Popular

Pro

For compliance professionals

$99 /month
billed annually · save 10%
Founding Member — rate locked
  • Everything in Free, plus:
  • Unlimited regulatory scans & custom radar alerts
  • Unlimited audit simulations
  • Advanced AI with Gemini Pro
  • Full QMSR gap analysis
  • Unlimited FMEA + CAPA management
  • Council Mode (metered allowance)
  • Document templates Roadmap
  • Citation validation & lookup
  • Priority email support

Auto-renews until you cancel: you'll be charged $99/month automatically each billing period. Cancel anytime via Manage Subscription.

New

Premium

The full QMS operating system

$399 /month
billed annually · save 10%
Founding Member — rate locked
  • Everything in Pro, plus the full QMS OS:
  • Management Review & Process Validation (ISO 13485 §5.6 / §7.5.6)
  • Quality Statistics toolkit (sampling, Cp/Cpk, Gage R&R)
  • Supplier quality bundle + AIAG tools (8D, PPAP, APQP)
  • Multi-standard gap analysis + Recall Effectiveness planner
  • Council Mode expanded allowance + API / webhooks
  • Managed Service overlay available

Auto-renews until you cancel: you'll be charged $399/month automatically each billing period. Cancel anytime via Manage Subscription.

Enterprise

Org-wide rollouts

Contact Sales
  • Everything in Premium, plus:
  • SSO + audit-trail export
  • Custom regulatory frameworks
  • Managed Service overlay
  • Dedicated CSM & SLA
Book a QMS.coach consult Contact on LinkedIn
One-time purchase · no account needed

QMSR Knowledge Pack, Edition 2026-11

Reference files, not a plan: the QMSR, FDA inspections, Part 11 / Annex 11 and 12 jurisdictions as 65 Markdown pages for Notion, Obsidian, Git or an AI assistant.

USD 129
per person, one edition
  • Former-QSR-to-ISO 13485 crosswalk, transition checklist and self-assessment questions with the record that answers each
  • Front matter and citations on every page; links to the official sources; no copyrighted standard text
  • Delivered by card checkout; download links on the confirmation page and by email
See the pack Free sample

Feature Comparison

Feature Free Pro Premium
AI Regulatory Scans ~5 per month Unlimited Unlimited + Council
Council Mode (multi-model) Metered allowance Expanded allowance
Regulatory Radar Browse only Custom alerts Custom alerts
Compliance Exposure View · 1 profile CAPA + PDF + unlimited CAPA + PDF + unlimited
Audit Simulations 3 per month Unlimited Unlimited
QMSR Gap Analysis Overview only Full Full + multi-standard
FMEA (PFMEA / DFMEA / USE) 3 FMEAs / 20 items Unlimited Unlimited
CAPA management
QMS OS suite (Mgmt Review, Validation, Quality Stats, Supplier, AIAG 8D/PPAP/APQP, Recall, multi-standard gap)
API access & webhooks
Document Templates Roadmap Roadmap Roadmap
Support Community Priority email Priority + Managed Service overlay

Roadmap = planned, not yet available. Everything else in this table is live today.

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