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January 18, 2015
The U.S. National Institute of Standards and Technology issued a document entitled “Framework for Improving Critical Infrastructure Cybersecurity” dated February 12, 2014.   This document is now being used by FDA as a reference in its cybersecurity program.  You can download version 1.0 here: Framework for Improving Critical Infrastructure Cybersecurity Version 1.0 See our later post...
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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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