A Narrative Review of FDA Human Factors Validation Requirement: The Needs of Key Stakeholders and Proposal of an Industry (Human Factors Service Providers) Maturity Assessment Tool
As part of a comprehensive Quality System Regulation (QSR), the human factors (HF) validation requirement by the Food and Drug Administration (FDA) is a relatively recent topic. Multiple issues and bottlenecks have emerged since the publication of the draft guidance in 2011. The scientific literature on the topic of ‘FDA HF validation requirement’ is mostly […]
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