MEDICAL HUMAN FACTORS
Comprehensive support for all your human factors activities and documentation.
Regulatory bodies such as the FDA and EU MDR expect a full set of human factors activities and documentation as part of medical device submissions. We partner with you to create human factors deliverables that are clear, defensible, and aligned with regulatory expectations.
Planning & Foundations
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Human Factors Plans - establish a clear human factors strategy
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Use Specifications - define intended users, use scenarios, and use environments
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Task and Workflow Analysis - map real-world interactions
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Known Use Errors (KUERs) - capture lessons from similar or legacy products
Risk Analysis
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Use-Related Risk Analysis (URRA) – connect use errors and tasks to associated risks and mitigations
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Critical Task Identification – highlight tasks where use errors could result in serious harm or compromised therapy
Studies & Protocols
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Formative Studies - evaluate early designs to inform design and reduce risks
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Summative/Usability Validation Studies - validate final designs to demonstrate safe and effective use
Reporting
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HFE/UE Reports - pull the story together for regulators
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Other Required Documentation tailored to your submission needs