Day

January 9, 2016
This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. It contains a training aid that provides an overview comparison between the 2015 Amendment of IEC 62304 and FDA requirements based on 62304 Safety Classes. SCPRed_SoftwareCPR-FDA-62304SafetyClasscomparisonTrainingAide
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http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm467223.htm
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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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