PreQMS · Professional plan Self-serve · monthly or annual
Plan / Professional

Cybersecurity and AI for your connected device.

Everything in Starter, plus FDA §524B cybersecurity, Fault Tree Analysis, the Readiness Assistant, and AI generation & review — for your connected-device submission.

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UNLOCKED Your module library
SRS Risk Analysis Test Cases V&V Use Case FTA Cybersecurity Readiness Assistant
✦ = unlocked on Professional · cybersecurity, FTA, AI & the Readiness Assistant
What's included

The connected-device toolkit, with AI

Professional adds everything a connected medical device needs for §524B, plus AI throughout your workflow.

Everything in Starter — the full non-cyber submission toolkit
Cybersecurity §524B & SBOM — the connected-device requirement
Fault Tree Analysis (FTA) — top-down safety analysis
Readiness Assistant — grounded chat over your own documentation
AI generation & review — draft and check requirements, tests & more
Up to 10 users — room for a bigger team on your submission
Priority support — faster help when you need it
Add an AI package anytime — Bronze, Silver, Gold or Platinum
Getting started

From signup to first export

Self-serve from day one — 1 project · up to 10 users.

1

Create your workspace

Sign up and set device attributes — Professional scaffolds cyber & FTA modules when your device connects.

2

Invite your team

Up to 10 working users with role-based access and a full audit trail.

3

Build with AI

Generate and review requirements, tests and cybersecurity content, grounded in your data.

4

Export submission docs

Generate 510(k)-ready Word outputs across every product.

Self-serve checkout

Start your Professional plan

A flat plan — pick monthly or annual, optionally add an AI package, and check out in minutes.

Professional plan

Review & check out

A flat monthly plan — no per-seat pricing. Includes 1 project and up to 10 users. Add an AI package for generation and review at volume.

Professional plan $1,399 / mo · 1 project · up to 10 users
Flat plan
Add an AI package  ·  optional · same packages as every AI-enabled plan
Your total billed monthly
$1,399 / mo
Need more than one product? Business unlocks unlimited projects and unlimited users with advanced permissions — for teams running multiple programs at once.