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

Your first 510(k) submission, fully documented.

Everything a small team needs to build a complete FDA 510(k) and IEC 62304 documentation set for non-connected software — requirements, risk, V&V, traceability, e-signatures and 510(k)-ready exports.

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UNLOCKED Your module library
SRS Risk Analysis Test Cases Test Procedures Design Use Case Traceability V-Model
Everything for a non-connected submission · unlimited modules & workspaces
What's included

The full non-connected submission toolkit

Starter unlocks the complete document toolkit for teams whose device does not connect to a network — no cybersecurity module needed.

Unlimited modules & workspaces — organize by product or project
Requirements, risk (ISO 14971) & V&V — the core submission spine
Traceability matrix & V-Model — link needs to evidence
21 CFR Part 11 e-signatures — controlled, auditable approvals
Baselines, locks & recovery — freeze and protect design inputs
510(k)-ready Word exports — generate submission documents
Roles & audit trail — editors, reviewers, viewers
Setup wizard — scaffold your modules in one click
Getting started

From signup to first export

Self-serve from day one — 1 project · up to 3 users.

1

Create your workspace

Sign up and set your device attributes — Starter scaffolds the right non-cyber modules for you.

2

Invite your team

Bring in up to 3 working users with role-based access and a full audit trail.

3

Build your documentation

Author requirements, risk, V&V and traceability with the setup wizard.

4

Export submission docs

Generate 510(k)-ready Word outputs straight from your modules.

Self-serve checkout

Start your Starter plan

A flat plan — pick monthly or annual and check out in minutes.

Starter plan

Review & check out

A flat monthly plan — no per-seat pricing. Includes up to 3 users and 1 project.

Starter plan $999 / mo · 1 project · up to 3 users
Flat plan
AI is available on Professional  ·  Starter does not include AI generation or credits
Want AI to draft and review your requirements, tests and cybersecurity content? Upgrade to Professional to unlock AI generation, the Readiness Assistant, and AI credit packages.
Your total billed monthly
$999 / mo
Building a connected device? Cybersecurity §524B, Fault Tree Analysis, the Readiness Assistant and AI generation all live on Professional — step up whenever your device connects to a network or you want AI in your workflow.