Day

August 3, 2008
This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Prepared this example Device Risk Management SOP for the purpose of risk analysis training where the pros and cons could be further discussed.  This example is modeled on the approach required by ISO 14971 and expands on it with...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. This reference manual includes select FDA documents as well as SoftwareCPR training aides and checklists that SoftwareCPR uses in its training courses on Validation of Clinical Trials Computer Systems. The PDF is over 2 MB so be patient downloading...
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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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