MDO Article: Five Qualities of a Good Use Risk Assessment (uFMEA)

What makes a use risk assessment good? Researcher Bryon Calawa answers that question in Design Science’s latest guest column for MedDeviceOnline.

After working with a wide variety of different products and use risk assessments, Bryon states that “there is a right way and a wrong way to complete an assessment.” He contends that it is worth the effort, time and care to invest in a good use risk assessment that will put your validation study on the “path to success.”

For Bryon’s five qualities of a good use risk assessment, read the full article here:


Looking for help with your use risk assessment? Design Science can help develop or revise your assessment as part of a human factors assessment package or as a standalone service. Design Science can also come to you and provide a use risk assessment workshop to get your team on the right path.

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The MDO article was adapted from a post initially edited by Lindsey Stefan.

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