FDA Draft Infusion Pump Guidance

The Food and Drug Administration (FDA) has posted a draft revised guidance for infusion pumps. This guidance is part of a major FDA initiative to enhance infusion pump safety. It has many references to software and software hazards. It also indicates an assurance/safety case should be provided rather than just a risk analysis. Although this guidance is for infusion pumps it may be indicative of the FDA’s future expectations for other devices and their software as well.

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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