FDA CDRH CADx Workshop Summary

On June 26, 1996 FDA held an open public workshop a on computer-aided diagnosis and medical devices as a step in developing further policy and guidances for such devices/software. Summaries of the presentations and participant comments are provided in this text.

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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