FDA CDRH 510(k) Sodium Test System

“Guidance for Industry In Vitro Diagnostic Sodium Test System.”

This guidance was issued July 6, 1998. Like other guidance documents related to IVD tests issued in this time frame, there is a short software section that requires software validation information and a certification statement in the submission. And there is a section on other device validaton information related to the methods and percision and liniarity and the statisics and calculations involved.

SoftwareCPR Keyword: IVD

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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