FDA Postmarket Cybersecurity Blog

FDA issued a Final guidance entitled: “Postmarket Management of Cybersecurity in Medical Devices”. The link provided is to FDA’s blog regarding this.
SoftwareCPR can provide expert cybersecurity consulting services for regulatory compliance andrisk analysis, technical threat and vulnerability assessment as well as for preparing premarket submission and post market information to FDA.

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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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