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Webinar: Applying Human Factors and Usability Engineering to Medical Devices
Автор: Invent Healthcare
Загружено: 2020-08-14
Просмотров: 3930
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This guidance for applying human factor and usability engineering will assist medical device developers in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses, and environment. The FDA recommends that manufacturers include human factors data in their premarket submissions (i.e., PMA, 510(k)) if an analysis of risk for the device indicates that users performing tasks incorrectly or failing to perform tasks could result in serious harm.
Slide: https://www.fda.gov/media/96064/download
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