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December 26, 2008
This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The pdf at the link provided contains a set of FDA reference documents and partial examples used in SoftwareCPR training courses on Validation of Production and Quality System Software and Part 11. This is just a partial set and...
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The key guidance document from FDA regarding the software documentation required in a premarket submissions for FDA including 510(k)s, PMAs, and IDEs is the “Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005  
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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:

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  • 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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