Services
From the first contextual interview to the final validation report, our team plugs into your program exactly where you need support โ backed by HF Workspace for full traceability.
Field research, interviews, and task analysis.
Iterative and validation usability studies.
Critical task and use error identification.
FDA & IEC 62366-1 aligned documentation.
01 โ Discover
We start where the device will actually be used โ the home, the OR, the infusion suite, the field โ to understand real users, real environments, and the workarounds people invent when a design doesn't quite fit.
02 โ Validate
Structured moderated studies โ from early formative rounds that catch use errors while changes are cheap, to summative human factors validation testing that stands up to regulatory scrutiny.
03 โ Analyze
We connect critical tasks and potential use errors directly to design mitigations โ creating a defensible, living risk analysis that evolves alongside the device design.
04 โ Submit
We assemble HFE reports the way reviewers expect to read them โ use specification, formative summary, risk analysis, and summative results, fully traceable and ready for FDA or notified body review.
05 โ Enable
We help internal teams build lasting human factors capability, not just a one-time deliverable.
A practical introduction to human factors engineering for R&D and quality teams.
Hands-on coaching for teams running their own formative usability sessions.
Get your team fluent in traceable HFE documentation from day one.