Information Disclosure for Diagnostic X-Ray System

Guidance for Industry and FDA Staff Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems

Document issued on September 5, 2003

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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