EWICS TC7 Medical Devices Subgroup Risk Paper

The link provided is a position paper on: Risk in Medical Devices. It discusses the unique aspects of risk versus benefits to be addressed in medical device risk management. It proposes a framework for consideration.

EWICS-WP8050-03

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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
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  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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