HFE Space

An AI-assisted, traceable workspace for human factors engineering.

HFE Space structures FDA and IEC 62366 human factors engineering work from Use Specification all the way through the HFE Report — while keeping expert judgment exactly where it belongs: in human hands.

Enter HFE Space Request a Demo See the Workflow
Use Specification
Task Analysis
Formative Studies
Risk Analysis
Summative Validation
HFE Report
Traceability Matrix

Infusion Pump — Program Traceability

User Needs
92%
Task Analysis
100%
Formative
78%
Risk Analysis
65%
Summative
30%

Why HFE Space

Built specifically for regulated human factors work

🔗

End-to-end traceability

Every user need, task, risk, and test result is linked — so your HFE report writes itself from real evidence.

🤖

AI-assisted drafting

Draft use scenarios, risk statements, and report sections in minutes instead of days.

🧑‍⚕️

Human-in-the-loop review

Every AI-generated draft is flagged for expert review before it becomes part of the design history file.

📐

FDA & IEC 62366-1 aligned

Structure and terminology map directly to FDA HFE/UE guidance and IEC 62366-1 usability engineering files.

Workflow

From Use Specification to HFE Report — one connected thread

HFE Space mirrors the way regulators actually read a usability engineering file, so nothing has to be reconstructed at submission time.

01

Use Specification

Define intended use, use environments, and use scenarios.

02

Task Analysis

Break down tasks and identify correct task flow.

03

Risk Analysis

Link use errors to harms and mitigations in a living risk record.

04

Formative Testing

Run and log iterative usability studies, tied directly to design changes.

05

Summative Validation

Structure simulated-use validation testing against critical tasks.

06

HFE Report

Generate a submission-ready report, fully traceable to source evidence.

Traceability

See the whole chain, in one view

Every row in the traceability matrix connects a user need to the evidence that closes it out.

User NeedCritical TaskRisk ControlVerification / ValidationStatus
Deliver correct dose without clinical oversight Program infusion rate Confirmation step before rate lock-in Summative Study S-03 Closed
Detect occlusion promptly Respond to occlusion alarm Distinct alarm tone + on-screen guidance Formative Round F-04 In Review
Set up device without training Load administration set Color-coded, keyed connector Formative Round F-02 Closed
Recover from power interruption safely Resume paused infusion Auto-resume confirmation prompt Summative Study S-03 Draft

Human + AI

AI accelerates the work. Engineers own the judgment.

HFE Space never submits a decision on its own. Every AI-drafted use scenario, risk statement, or report section is clearly marked as a draft until a qualified human factors engineer reviews, edits, and signs off — preserving a clear audit trail of who decided what, and when.

  • Draft / Reviewed / Approved states on every artifact
  • Full edit history and reviewer attribution
  • Exportable audit trail for regulatory review
Human factors engineer reviewing AI-assisted analysis on a laptop

Pricing

Simple plans for individual HFE professionals

Every plan includes the full core HFE workflow, all three regional regulatory foundations, and full traceability. Plans differ only in capacity — how many projects you can run at once, and how much AI-assisted drafting you get each month.

Individual Free
$0

7 days, no card required

  • 1 active project
  • 30 one-time points
  • Full core HFE workflow
Start Free Trial
Individual Plus
$6.99/mo

First month $3.99, then $6.99/mo

  • 1 active project
  • 120 points / month
  • One project at a time
Subscribe
Individual Pro
$14.99/mo

Billed monthly

  • 5 active projects
  • 500 points / month
  • Personal knowledge library
Subscribe
Individual Max
$39.99/mo

Billed monthly

  • 20 active projects
  • 1,000 points / month
  • For high-volume consultants
Subscribe

Add-ons & Top-ups

Points cover AI-assisted drafting and analysis — everyday viewing and editing is always free. Beyond these subscription plans, HFE Space also offers extra project slots and one-time Points top-ups on top of any plan. Log in to HFE Space to view current add-on pricing and purchase.

View Add-ons & Top-ups

FAQ

Common questions about HFE Space

Does HFE Space replace our human factors engineers? +
No. HFE Space accelerates drafting, organization, and traceability, but every scenario, risk statement, and conclusion is reviewed and approved by a qualified human factors engineer — either from your team or ours.
Which regulations does it align with? +
HFE Space's structure and terminology map to FDA's Human Factors and Usability Engineering guidance and IEC 62366-1, so your documentation follows a structure reviewers already recognize.
Can it integrate with our existing QMS? +
HFE Space is designed to sit alongside your quality management system, exporting traceability matrices and HFE report content in formats your document control process already supports.
How does billing work? +
You can pay monthly or annually and cancel anytime. Upgrades apply immediately; downgrades and cancellations take effect at the end of your current billing period, so you always get what you already paid for.
What are Points, and do they roll over? +
Points cover AI-assisted operations — drafting, analysis, and report generation. Everyday viewing and editing is always free. Your monthly Points reset each billing period and don't roll over, but Points top-ups stay valid for 365 days from purchase.
What happens to my projects if I downgrade or cancel? +
Nothing is ever deleted. If a downgrade puts you over your new project limit, the extra projects simply become read-only until you archive one or upgrade again — and you can export your raw data at any time, even on a cancelled or read-only account.
Is annual billing cheaper than paying monthly? +
Yes — every plan's annual price works out to less than paying month-to-month for a year.