FDA Intel Pentium Problem Letter

FDA CDRH’s letter 14-Feb-1994 regarding the Intel Pentium floating point calculation defect. This is a good example of how serously FDA takes problems with components and indicates what FDA expects of the manufacturer.

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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