FDA Infusion Pump Software Safety Research

The FDA’s Software Engineering Laboratory has performed or been involved in a number of activities related to infusion pump safety, model based development and static analysis. The link provided is to FDA’s primarary web page on these activities.

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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