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January 10, 2017
FDA issued a safety notice: Cybersecurity Vulnerabilities Identified in St. Jude Medical’s Implantable Cardiac Devices and Merlin@home Transmitter.
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Sandy Hedberg of SoftwareCPR prepared a summary of the impact of the December 13, 2016, U.S. law, the 21st Century Cures Act on Standalone Software. Section 3060 addresses standalone software and exempts some software from regulation as a medical device. Sandy’s summary is at the link provided: 21st Century Cures Act – Software CPR Analysis....
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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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