FDA CDRH Rosencrans Submissions Presentation

Heather Rosencrans of the FDA’s Device Center Office of Device Evaluation gave a presentation on May 16, 2005 that is a useful reference on the 510(k) process, when to submit for changes, uses of the appeal process and strategies for successful submissions. The slides from the presentation are at the link provided.

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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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