FDA Health Hazard Evaluation Form

FDA published a notice regarding its Health Hazard Evaluation Form. Its not software specific and is for after the fact analysis of something in the field but has items and concepts that might help as well in development risk analysis or when evaluating field issues related to software. The form is at the link provided.

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

Email office@softwarecpr.com
for more info!

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