Day

November 8, 2009
This topic includes links to software safety guidance from other safety related industries that have useful information that could be applied to medical device software. All of these and sometimes others are in the document library section of the website.
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For those using or interested in the SEI’s Capability Maturity Model, the link provided contains a white paper comparing IEC 62304 and the CMMi. This white paper was prepared by David Walker, a consultant that is a licensed SEI partner. It is published here with his permission. 62304-CMMi-comparison-DWalker092909
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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

Email office@softwarecpr.com
for more info!

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