Safety Model Article – FDA co-author

“Safety Models: An Analytical Tool for Risk Analysis of MedicalDevice Systems” by co-author Paul Jones of FDA CDRH’s Office of Science and Technology. This article discusses use of markov chain usage models for medical device Risk Management. This article was provided with permission by Paul Jones.


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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