About IMOT

Human-centered engineering, built in Shanghai for medical device teams everywhere.

IMOT was founded on a simple conviction: devices are safest when the people who will actually use them are placed at the center of every design decision — and every one of those decisions should be traceable.

Our Story

Why we started IMOT

We kept seeing the same pattern across medical device programs: strong engineering, real clinical insight, and yet human factors work treated as a compliance checkbox — assembled late, scattered across documents, and hard to defend under regulatory review.

IMOT was built to close that gap. We pair experienced human factors engineers with an AI-assisted workspace so that use specifications, formative findings, risk analyses, and validation evidence live in one connected, traceable record — from the first user interview to the final HFE report.

We work as an extension of our clients' teams, not a black box: every AI-assisted draft is reviewed, edited, and owned by a qualified human factors engineer before it ever reaches a regulator.

Engineer reviewing device usability data in the lab

What We Believe

Our ethos

🎯

Users first, always

Every recommendation traces back to observed user behavior, not assumption.

🔗

Traceability is non-negotiable

If a decision can't be traced from user need to validation evidence, the work isn't done.

🤝

AI assists, humans decide

Our tools accelerate documentation and analysis — expert judgment stays firmly in human hands.

📚

Teach as we work

We share our methodology openly through Insights so the wider device community benefits.

🌏

Global standards, local presence

Grounded in Shanghai, fluent in FDA and IEC 62366-1 expectations worldwide.

⚖️

Rigor without bureaucracy

Regulatory-grade documentation, without the drag of legacy processes.

Where We Are

Grounded in Shanghai, working with device teams worldwide

Our home office in Shanghai anchors a team that regularly supports clients across North America, Europe, and Asia-Pacific — conducting research locally and collaborating remotely through HFE Space.

✓Shanghai, China — Headquarters
✓Remote-friendly delivery for global programs
✓Bilingual documentation support (English / Chinese)