FDA Presentation Update on Part 11

John Murray FDA’s Device Center Part 11 expert gave an update on Part 11 electronic records and signatures at AdvaMed Medical Technology Software Conference that was held on November 8-9, 2006 . His slides are at the link provided and discuss the direction being considered for revising the regulation, narrowing scope, and reducing it prescriptive nature.

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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