FDA CDRH 510(k) Reqs for Firms Initiating Recalls

FDA Blue Book Memorandum K95-1 “510(k) Requirements During Firm-Initiated Recalls”. Is at the link provided. It explains and provides a flowchart on the options. Note that it indicates FDA needs to be in the loop and agree with choices and approach during a reportable recall.

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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