About IMOT
亿姆特(上海)科技有限公司 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
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.
What We Believe
Every recommendation traces back to observed user behavior, not assumption.
If a decision can't be traced from user need to validation evidence, the work isn't done.
Our tools accelerate documentation and analysis — expert judgment stays firmly in human hands.
We share our methodology openly through Insights so the wider device community benefits.
Grounded in Shanghai, fluent in FDA and IEC 62366-1 expectations worldwide.
Regulatory-grade documentation, without the drag of legacy processes.
Who We Are
Human factors, industrial design, regulatory affairs, and software engineering working from a shared playbook.
Where We Are
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 HF Workspace.