January 6, 2014
Company: Nipro Diganostics Date of Enforcement Report:1/6/2014 Class lI: PRODUCT TRUEbalance and TRUEtrack blood glucose meters distributed in the U.S., Europe, Asia and Canada, the company said Thursday. REASON The affected meters ? 501 TRUEbalance and 105 TRUEtrack ? may have a flaw in the factory-set unit of measure that would cause them to measure...
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SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

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

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