FDA Draft Guidance Flow Cytometry Devices

The FDA issued a draft gudance entitled “Flow Cytometric Devices” dated 14-Oct-2014. Section 5 of this guidance addresses softwrae used in the device and discusses regualtory clearance with the associated reagents and instrumentation as well as other information needed. The full guidance is at the link provided and was issues jointly by the Office of In Vitro Diagnositcs Division of Immunology and Hematology and the Center for Biologics Evaluation and Research.

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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