Our healthcare human factors and medical device experts utilize deep understanding of human behavior and cognition and apply scientific usability principles to help clients design and develop products that are safe and effective.
We assist clients to ensure products are aligned with Food & Drug Administration (FDA) guidance, help achieve 510(k) clearance and pre-market approval (PMA), and support in meeting expectations of the De Novo pathway.
As trusted healthcare and medical device human factors partners, we collaborate with leading healthcare and life sciences organizations to deliver support at every stage of the product lifecycle. We are engaged by leading medical device, cosmetics, pharmaceutical, and healthcare technology organizations for our deep expertise in applying human factors principles to complex product development. We provide clients-including healthcare and life science companies, manufacturers, law firms, and government agencies-with evidence-based usability insights, risk mitigation strategies, and actionable data sets that inform design decisions, enhance user safety, and support successful regulatory submissions.
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