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.
Why HFE Space
Every user need, task, risk, and test result is linked — so your HFE report writes itself from real evidence.
Draft use scenarios, risk statements, and report sections in minutes instead of days.
Every AI-generated draft is flagged for expert review before it becomes part of the design history file.
Structure and terminology map directly to FDA HFE/UE guidance and IEC 62366-1 usability engineering files.
Workflow
HFE Space mirrors the way regulators actually read a usability engineering file, so nothing has to be reconstructed at submission time.
Define intended use, use environments, and use scenarios.
Break down tasks and identify correct task flow.
Link use errors to harms and mitigations in a living risk record.
Run and log iterative usability studies, tied directly to design changes.
Structure simulated-use validation testing against critical tasks.
Generate a submission-ready report, fully traceable to source evidence.
Traceability
Every row in the traceability matrix connects a user need to the evidence that closes it out.
| User Need | Critical Task | Risk Control | Verification / Validation | Status |
|---|---|---|---|---|
| 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
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.
Pricing
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.
7 days, no card required
First month $3.99, then $6.99/mo
Billed monthly
Billed monthly
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.
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