Day

July 20, 2014
In SoftwareCPR training classes on IEC 62304 and FDA regulation we sometiems use a fabricated exmple of a vertical slice of software documentation. This example includes requirements specification, risk annalysis, design and testing along with commentary for one functional area. The document at the link provided provides this using the calibration portion of an in-vitro...
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http://www.advisory.com/Daily-Briefing/2014/07/16/Google-wants-a-piece-of-the-eye-teams-up-with-Novartis-on-smart-contact-lenses
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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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