• Lean On (Your Formatives)

    By Corinna Proctor, MS The FDA and ANSI/AAMI/IEC 62366-1 provide guidance on the device design process and where human factors formative studies fit in, and what is expected. If the agency sees your submission with no Formative usability work, your submission may be ‘flagged.’ After many years in the business, we are still seeing go-to-market […]

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