HFE Space
HFE Space is an AI-assisted, traceable human factors engineering workspace for medical device teams — structuring FDA / IEC 62366 HFE work from Use Specification through the HFE Report, while keeping expert judgment in human hands.
Why HFE Space
Most HFE programs lose traceability somewhere between the use specification and the final report — scattered spreadsheets, disconnected review cycles, evidence that's hard to reconstruct under a reviewer's questions. HFE Space keeps every user need, task, risk, and mitigation linked in one workspace, from day one through submission.
Every stage of your HFE program lives in the same connected workspace — nothing gets lost between a use specification and a validation report.
Users, use environments, and use scenarios defined early and kept current across the program.
Structured formative usability testing surfaces use errors while design changes are still cheap.
Critical tasks and use errors are linked directly to mitigations and design controls.
Summative validation and a fully traceable HFE report package aligned to FDA and IEC 62366-1.
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.
