FDA-Premarket Submission Cybersecurity Info Draft

In a new draft guidance (for electrosurgical devices; but in our opinion representative of information needed for other devices) FDA stated that cybersecurity information including but not limited to the following should be provided:

  • Confidentiality assures that no unauthorized users have access to the information.
  • Integrity is the assurance that the information is correct – that is, it has not been improperly modified.
  • Availability suggests that the information will be available when needed.
  • Accountability is the application of identification and authentication to assure that the prescribed access process is being done by an authorized user.

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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