Free
Explore PreQMS
Starter
Build one submission
Professional
Cybersecurity + AI
Business
Scale your operation
Every plan builds toward a defensible FDA 510(k) submission. Higher plans add cybersecurity, AI, and scale — never a compliance shortcut.
How to read this: Starter covers non-connected software end-to-end. Because FDA §524B cybersecurity is a refuse-to-accept gate for connected devices, cyber tooling starts at Professional — if your device connects to a network, Professional is your entry plan. Consultancies managing multiple clients use MSP, which includes everything.
| Feature | Free$0 | Starter$999/mo | Professional$1,399/mo | Business$1,799/mo |
|---|---|---|---|---|
| Plan limits | ||||
| Projects | 1 | 1 | 1 | Unlimited |
| Users | 1 | 3 | 10 | Unlimited |
| AI credits | 3 one-time (trial) | — | Add-on | Add-on |
| Core platform | ||||
| Device-attribute setup & auto-scaffold | ✓ | ✓ | ✓ | ✓ |
| Module authoring | Up to 3 | ✓ | ✓ | ✓ |
| 510(k) readiness score & gap list | Core | ✓ | ✓ | ✓ |
| Command Center (readiness cockpit) | — | ✓ | ✓ | ✓ |
| Row versioning & history | ✓ | ✓ | ✓ | ✓ |
| Requirement quality scoring | Core | ✓ | ✓ | ✓ |
| Word (.docx) import & export | Core | ✓ | ✓ | ✓ |
| Compliance & submission | ||||
| Requirements management (SRS / System) | Core | ✓ | ✓ | ✓ |
| Traceability matrix | Core | ✓ | ✓ | ✓ |
| Traceability browser & V-Model | — | ✓ | ✓ | ✓ |
| Evidence chain & Safety-Critical KPI | — | ✓ | ✓ | ✓ |
| Risk management (ISO 14971) | Core | ✓ | ✓ | ✓ |
| Fault Tree Analysis (FTA) | — | — | ✓ | ✓ |
| Verification & Validation | — | ✓ | ✓ | ✓ |
| Baselines (design-input freeze) | — | ✓ | ✓ | ✓ |
| 21 CFR Part 11 e-signatures | — | ✓ | ✓ | ✓ |
| Cybersecurity §524B & SBOM | — | — | ✓ | ✓ |
| Readiness Assistant (grounded chat) | — | — | ✓ | ✓ |
| Collaboration & review workflow | ||||
| Comments & mentions | — | ✓ | ✓ | ✓ |
| Real-time presence & edit locks | — | ✓ | ✓ | ✓ |
| Review assignments & multi-reviewer sign-off | — | ✓ | ✓ | ✓ |
| Module status lifecycle | — | ✓ | ✓ | ✓ |
| Artifact rubric review | — | ✓ | ✓ | ✓ |
| AI (credit-metered) | ||||
| AI document & requirement generation | — | — | ✓ | ✓ |
| AI test-case & use-case generation | — | — | ✓ | ✓ |
| AI requirement review & traceability analysis | — | — | ✓ | ✓ |
| Add-on AI credit packages (Bronze→Platinum) | — | — | Add-on | Add-on |
| Administration & support | ||||
| Role-based permissions | ✓ | ✓ | ✓ | ✓ |
| Advanced / granular permissions | — | — | — | ✓ |
| Priority support | — | — | ✓ | ✓ |
| Core = a limited or preview version of the feature. ✓ = included. — = not in this plan. Add-on = available via AI credit packages. Need SSO, procurement, IQ/OQ/PQ, or volume pricing? Contact sales. | ||||