Medical Device Software Recalls Summary 2007

In an AAMI Webinar John Murray of FDA indicated that it appears that software issues comprise 16 percent of medical device recalls and there is some thought to developing some special procedures for handling these. SoftwareCPR has found approximately 75 recalls related to software as of the end of November 2007 for the year which is about the same total as 2006 for the year.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email for more info.

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