FDA Physiological Closed Loop Workshop

FDA held a public workshop October 13-14, 2015 entitled “Public Workshop – Physiological Closed-Loop Controlled Devices”.Webcasts and other outputs from this workshop are avaialbel 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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Partners located in the US (CA, FL, MA, MN) and Italy.