[Emergo, UL] What Does it Mean for a Device to be Inherently Safe by Design?

Both the FDA’s Human Factors Engineering (HFE) guidance and the global HFE standard IEC-62366 list “inherent safety by design” as the most effective method of managing use-related risks associated with medical devices. In this article, we discuss what is meant by safety by design, provide examples of products that demonstrate it and explore how it can be implemented within medical device design.  

 

 

Inherent Design Safety | Emergo by UL

What Does it Mean for a Device to be Inherently Safe by Design?

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