Day

April 1, 2003
A white paper at the link provided gives an overview of the status of European Union medical device software regulation and provides suggestions on software validation. Some of the suggestions are based on FDA guidance documents. CMD Swartikel This paper was provided by Poul Schmidt-Andersen of Copenhagen Medical Devices which is an affiliate of SoftwareCPR.
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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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