FDA Software Presentation – Compliance Science

The slides from a presentation by FDA’s Device Center Software and Part 11 Compliance expert (John Murray) are attached. These were presented at a conference on March 19 and reflect some of the contents and concepts of internal FDA training on software regulation. The title of the presentation is Compliance Science and it focuses on critical thinking, flexibility and risk focus as does the newly released AAMI TIR36 with which John Murray was involved.

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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