Day

March 5, 2015
Company:Hospira Inc..Date of Enforcement Report: 5/28/2014 Class l: PRODUCT Plum A+ infusion pumps and Plum A+3 infusion pumps REASON he Plum A+ and A+3 infusion pumps have an alarm that should sound when a therapy is interrupted. Some of the alarms may fail to sound in situations that should trigger it. It is possible for...
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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

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