Day

September 18, 2013
General Hearing Instruments, Inc.. Product: ready-wear-air conduction hearing aids Date: 9/18/2013 This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC Section 351(h)], because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation do not conform with the Current...
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Company: B Braun Medical, Inc. Date of Enforcement Report: 9/18/2013 Class lI: PRODUCT Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative...
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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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