A submission-ready documentation workspace for your team.

Everything an in-house medical-device team needs to build FDA 510(k) and IEC 62304 documentation — unlimited modules, the full toolkit, and 510(k)-ready exports. Start with 1–5 seats and check out yourself.

Start your plan → or talk to sales

UNLOCKED Your module library

SRS Risk Analysis Test Cases Test Procedures Design Use Case FTA Cybersecurity

✦ = unlocked on Business · unlimited modules, unlimited workspaces

What's included

The complete documentation toolkit

Business removes every limit on the Free plan and unlocks the full set of module types and document tooling.

Unlimited modules — incl. FTA, Use Case & Cybersecurity

Unlimited workspaces — organize by product or project

Setup wizard, locks & recovery — scaffold and protect your documentation

510(k)-ready exports — Word, PDF & Excel

Requirement traceability — across every module

Roles & audit trail — editors, reviewers, viewers

10 AI credits to start — one-time, on the house

Add an AI package anytime — Bronze, Silver or Gold

Getting started

From checkout to first export

Self-serve from day one — no sales call needed for teams of five or fewer.

Choose your seats

Start with 1–5 working seats. Add more anytime up to five — reviewers and viewers are always free.

Invite your team

Bring in editors, reviewers and viewers with role-based access and a full audit trail.

Build your documentation

Use the setup wizard to scaffold SRS, risk, use-case, FTA and cybersecurity modules.

Export submission docs

Generate 510(k)-ready Word, PDF and Excel outputs straight from your modules.

Self-serve checkout

Build your plan

Pick your seats, optionally add an AI package, and check out in minutes. Teams of six or more go through sales.

Business plan

Configure & check out

Every seat includes the full toolkit and 10 starter AI credits.

Seats $199 / user / mo

Add an AI package · optional, same packages as every plan

Your total billed monthly · 10 AI credits included

$398 / mo

Growing past five? You can add up to 5 seats yourself, right inside the app. For teams of six or more, talk to sales and we'll set up volume pricing and any contract, security-review or SSO needs — that's where Enterprise begins.