{"id":6604,"date":"2026-02-23T14:57:50","date_gmt":"2026-02-23T05:57:50","guid":{"rendered":"https:\/\/uism.co.jp\/?page_id=6604"},"modified":"2026-04-02T21:13:03","modified_gmt":"2026-04-02T12:13:03","slug":"human-factors-research","status":"publish","type":"page","link":"https:\/\/uism.co.jp\/en\/human-factors-research\/","title":{"rendered":"Human Factors Research_en"},"content":{"rendered":"\n
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Services<\/strong><\/p>\n\n\n\n

Human Factors Research<\/strong><\/h2>\n\n\n\n

We help you identify use-related risks early, iterate with confidence, and build evidence that supports PMDA review when needed.<\/strong><\/span><\/strong><\/span><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n\n\n\n

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Compliance Is the Baseline; Safe Use Is the Goal <\/strong><\/h2>\n\n\n\n

Human factors (HF) work starts long before validation, because safe use is shaped by the context of use<\/strong>. We evaluate your device within Japanese clinical workflows and care environments to identify risks early and support iteration before designs become fixed. This creates a stronger foundation for summative validation and PMDA review<\/strong>.<\/p>\n<\/div><\/div><\/div><\/div><\/div>\n\n\n\n

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HF Support Across Every Stage<\/strong><\/strong><\/h2>\n\n\n\n

We follow an IEC 62366-1 aligned approach to generate evidence that supports both development and review.<\/p>\n\n\n\n

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Early Stage Exploratory Research<\/strong><\/h3>\n\n\n\n

Mapping Real Use in Japan<\/strong><\/span><\/h4>\n\n\n\n

We start by understanding where and how your device fits into Japanese healthcare environments, including hospitals, clinics, and home care. This phase surfaces latent risks, unmet needs, and workflow constraints before designs become rigid.<\/p>\n\n\n\n

Methods:<\/p>\n\n\n\n