Arrhythmia Detector and Alarm

Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm; Guidance for Industry and FDA Staff
Document issued on October 28, 2003
The draft of this document was issued on December 13, 2002

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

for more info!

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