FDA CDRH Hemodialysis Delivery 510(k) Guidance

FDA CDRH Office of Device Evaluation’s “Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems” issued August 7, 1998.. Section VII D addresses software by referencing the general software and Off-the-shelf software Submission guidances and providing some information on how the software documentation should be organized in the Submission. In the labeling section it indicates that the model number and software version number for the medical device should be indicated in the Device Labeling.

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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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