July 12, 2019
Company: Hamilton Medical Date of Enforcement Report: 7/12/2019 Class I PRODUCT Hamilton Medical AG Hamilton-G5 Ventilator (PN 159001) Recall Number: Z-1874-2019 REASON New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted....
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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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