FDA UDI Final Rule &Draft Guidance Overview Slides

FDA published slides presented by Jay Crowley of CDRH providing an overview of the Final Universal Device Identification Rule and the draft guidance. These slides highlight some of the important aspects of the final rule including changes from the draft rule. This includes that standalone software need only provide a means to display a human readable UDI. The full presentation is at the link provided.

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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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