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. Other sections of the act address medical devices and pharmaceuticals in general.
62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors: Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates: February 4-6, 2020
Registration Link
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QSS Software Validation
Planned Instructors: Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates: June 2-4, 2020
Registration Link
