UL’s Linda Chatwin, Maureen Mulcare and Jeff Rongero, recently published an article in Medical Design Briefs titled “Safety and Human Factors Engineering in Medical Device Design.”
As the article states, “Ultimately, manufacturers must validate that the product’s users can employ the device safely and effectively in the intended use environments” which is why Usability is one of the reasons regulators have been asking for additional information on submissions, which can cause delays in product commercialization. You can read the article below.
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