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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Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

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15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.