FDA New Digital Health Health and SaMD Initiative

Sandy Hedberg of SoftwareCPR suggests those involved in Health IT or Software only medical devices (SaMD) might find the recent comments by FDA commissioner Scott Gotlieb regarding FDA’s move to a new regulatory approach of interest. The link provided is to his blog positng.

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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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