Day

February 19, 2015
Inovo, IncProduct: AccuPulse Model 6505 oxygen conserver, Bonsai Velocity oxygen conserver, Evolution oxygen conserver, Evolution with Motion oxygen conserver, SmartDose oxygen conserver, Smart Does Mini oxygen conserver, Oxymizer Disposable oxygen conservers, and oxygen Regulators. Date: 2/19/2015 4. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). Specifically,...
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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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