AAMI proposes Human Factors Software Standard

The AAMI Human Factors committee has proposed a work item to develop a new standard: “AAMI/HE N245R2, Human factors engineering design processes for medical device software not considered a medical device”.The current proposal is the scope would be Heath IT user interface engineering for software not considered part of a medical device.

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Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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