Day

May 1, 2014
Lucille Ferus a Partner at SoftwareCPR provided training to the Tawian FDA on US and international medical device software regulation in April. We continue to see increased focus on software regulation in countries outside the US..
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Company: Baxter Healthcare CorporationDate of Enforcement Report:2/7/2014 Class I: PRODUCT Sigma Spectrum Infusion Pumps with Master Drug Library Model No. 35700BAX and 35700ABB Affected products were manufactured from July 1, 2005 through January 15, 2014 and distributed from February 20, 2013 through January 15, 2014. Use: Sigma Spectrum Infusion Pumps with Master Drug Library are...
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CSV Training Course

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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