FDA CBER Workshop Transcipt BECS 510(k)s

Attached is a transcript of a 2 day workshop held in November 2009 by FDA on preparing 510(k)s for Blood Establishment Computer Software.

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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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