$SoftwareCPR 62304 Training Template Manual $

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The pdf at the link provided contains selected templates used in SoftwareCPR training on medical device software standards focused on IEC 62304. These are not intended to be ideal for all situations or comprehensive but are intended to serve as input for discussion and process planning. These are provided for use in your company but not for external distribution.

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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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