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IEC 82304-1:2016 Health software - Part 1: General requirements for product safety
By Mitch on Tuesday, 1 November 2016, 21:09 - Standards
IEC 82304-1:2016, the missing link on standalone medical device software validation has been published!
See the official version on IEC webstore, and comments made on the FDIS (the final version shouldn't have changed).
Now we wait for the FDA to recognize it and the EU to harmonize it!