Lecture 8_Story

Lecture 8_Story - Human Factors and the FDA Molly Follette...

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Human Factors and the FDA Molly Follette Story, PhD Human Factors and Accessible Medical Technology Specialist FDA / CDRH / ODE Drexel University – May 18, 2011
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Overview Introduction to Human Factors Regulatory Basis for Human Factors at FDA Analytical Human Factors Methods Formative Studies for Device Design Human Factors Validation Testing Discussion Intro Regulations Analysis Formative Validation Discussion
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Human-Machine Interface Human Machine Information Processing Processing Information Perception Input Control Actions Output Intro Regulations Analysis Formative Validation Discussion
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Medical Device Use Intro Regulations Analysis Formative Validation Discussion
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Device Users Professional or non-professional Job title and responsibilities Age and functional capabilities Physical, sensory/perceptual, cognitive/intellectual Knowledge and experience levels Mental and emotional condition Intro Regulations Analysis Formative Validation Discussion
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Device Use Environment Clinical environment(s) Rehabilitation, assisted living, long-
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Lecture 8_Story - Human Factors and the FDA Molly Follette...

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