FDA Letter to Infusion Pump Manufacturers

The Food and Drug Administration (FDA) has posted a letter is sent to infusion pump manufacturers as part of a major initiative to enhance infusion pump safety. In this letter FDA mentions software issues as a focus and offers to provide free static analysis of the software. It also strongly recommends early interaction with FDA prior to premarket submissions. The full letter is at the link provided

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

Email office@softwarecpr.com
for more info!

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