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sw91
On Jan 14, 2019, FDA recognized ANSI AAMI SW91:2018 Classification of defects in health software.  The FDA recognition statement for this standard does not indicate any specific use in premarket submissions or relevant FDA guidances. It simply states it supports existing policies.  This standard is lengthy and technical in terms of its approach to defect...
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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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