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USFDA Guidance: Content of Human Factors Information in Medical Device Marketing Submissions
Human factors engineering focuses on understanding how users interact with medical devices and applying that knowledge to design safer and more effective products. The FDA explains that user interface design can significantly impact patient safety, as user errors may lead to incorrect treatment, delayed therapy, compromised medical care, or patient harm. Manufacturers routinely perform human factors assessments during device development to identify and mitigate use-related ri
Sharan Murugan
4 hours ago4 min read