Timeline of Key FDA Software Documents

This slide provides a timeline that identifies some of the key documents related to regulation of software for medical devices, pharmaceuticals, and biologics. It shows clearly the increasing focus on software validation in recent years.

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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