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September 16, 2019
The 2015 Amendment 1 update to IEC 62304 added a new clause that requires identification of “categories of defects associated with the selected programming technology” and providing analysis and other evidence demonstrating “that these defects do not contribute to unacceptable risk.”  Read a recent article on challenges with using C language.
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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

Email office@softwarecpr.com
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