FDA CDRH 510(k) Draft Version Neuro Endoscope

“Draft Version Neuro Endoscope Guidance”

This guidance was released in draft form July 7, 1994. It mentions software in several locations explicitly and asks for block diagrams of all components including software as applicable. It references the now obsolete old FDA software guidance document, “Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review,” and at this point users should know to use the current software submission guidance, “Guidance for the Content of premarket Submissions for Software Contianed in Medical Devices.” It also mentions descriptions of software if software is involved in any changes to the device. It talks about methods of verification of resolution if digital signal processing is used.

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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