HF Workspace
HF Workspace structures FDA and IEC 62366 human factors engineering work from Use Specification all the way through the HFE Report â while keeping expert judgment exactly where it belongs: in human hands.
A dedicated platform for Human Factors professionals.
Join HF WorkspaceAlready a member?
Access HF WorkspaceWhy HF Workspace
Every user need, task, risk, and test result is linked â 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
HF Workspace mirrors the way regulators actually read a usability engineering file, so nothing has to be reconstructed at submission time.
Define intended users, use environments, and use scenarios.
Break down critical tasks and identify where use errors could cause harm.
Run and log iterative usability studies, tied directly to design changes.
Link use errors to harms and mitigations in a living risk record.
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
HF Workspace 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 â preserving a clear audit trail of who decided what, and when.
FAQ