$SoftwareCPR Medical Device SW Reference Manual$

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This reference manual includes the following documents in a single pdf with bookmarks and a clickable TOC. Be sure to click bookmarks in adobe so you can jump around the document easily. This pdf contains key FDA software guidances plus a number of Software educational aides and article reprints.

It is a 2 MB adobe file so be patient downloading if you have a . . .

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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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