AI-Assisted Human Factors Engineering

Engineering medical devices people can use safely, the first time and every time.

IMOT (Shanghai) Technology Co., Ltd. partners with medical device and combination product teams to run rigorous, human-centered design programs — and to keep every use-related decision traceable through HF Workspace, our AI-assisted engineering platform built for FDA and IEC 62366 workflows.

Explore HF Workspace Talk to Our Team

IEC 62366-1& FDA HFE/UE aligned methodology

Use Spec → ReportEnd-to-end traceability

Human + AIExpert judgment stays in human hands

Clinician evaluating a medical device interface during a usability session

🩺 Live usability session — formative testing, infusion interface

Who We Are

A human factors partner built for the AI era

亿姆特（上海）科技有限公司 — IMOT brings together human factors engineers, industrial designers, and regulatory specialists who believe the best medical devices are built around the people who use them. We combine hands-on HFE consulting with HF Workspace, our own AI-assisted platform, so nothing gets lost between a use specification and a validation report.

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Use Specification

Frame the use context

Users, use environments, and use scenarios defined early and kept current across the program.

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Formative Study

Test early, iterate fast

Structured formative usability testing surfaces use errors while design changes are still cheap.

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Risk Analysis

Use-related risk analysis

Critical tasks and use errors are linked directly to mitigations and design controls.

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HFE Report

Submission-ready evidence

Summative validation and a fully traceable HFE report package aligned to FDA and IEC 62366-1.

What We Do

Two disciplines, one connected practice

Deep human factors expertise and AI-assisted tooling reinforce each other — our engineers write the articles, and shape the workspace they wish they'd always had.

Product

HF Workspace

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.

✓Full traceability from user needs to validation evidence
✓AI drafts, engineers decide — nothing ships without review
✓Built around FDA HFE/UE guidance & IEC 62366-1

See How It Works

Human factors engineer reviewing research notes

Knowledge

Human Factors Insights

Practitioner-written articles on usability engineering, use-related risk, and regulatory strategy — the same thinking that shapes our consulting work and HF Workspace, shared openly with the device community.

✓Formative & summative testing methodology
✓FDA & IEC 62366-1 regulatory interpretation
✓Applied AI in human factors practice

Read the Articles

Services

End-to-end human factors engineering

From early user research to final regulatory submission, our team plugs in wherever your program needs support.

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Usability & Contextual Research

Contextual inquiry, user interviews, and task analysis to ground design in real use environments.

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Formative & Summative Testing

Moderated usability studies, simulated-use validation, and knowledge task assessments.

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Regulatory HFE Submissions

Use-related risk analysis and HFE reports structured for FDA and IEC 62366-1 review.

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