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At a 1-day current regulatory topics session by ASQ held in Needham, MA, on June 16, 2005, Alan Kusinitz, Managing Partner of SoftwareCPR®, gave a presentation on the recent FDA Cybersecurity Guidance and the new revised FDA "Guidance for the Content of Premarket Submissions for Devices Containing Software." A pdf of the slides used are at the link provided.
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