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If your human factors validation study is inadequate, the FDA can bounce your entire submission back. Consequently forcing you to revise your submission file — or worse, your actual design — and [...]

Human factors validation testing shows you’ve done your due diligence to mitigate identified hazards and the resulting harms your device might cause users and patients. For the majority of [...]

Developing a medical device is already a long, involved, and often expensive process. Adding time and personnel to conduct human factors engineering (HFE) seems like a high cost addition, and for [...]

To market any type of product successfully, it’s important to identify how people will use it and what difference it will make in their lives. Put simply: You must understand your end users’ [...]