SoftwareCPR enhanced V diagram

A V diagram is commonly used to depict development activities (left side) and their V&V activities (right side). SoftwareCPR uses a variety of such diagrams in its trainng courses. Brian Pate of SoftwareCPR enhanced these diagrams in a variety of ways and the latest version is at the link provided. It depicts design control elements, software activities and high level relationships. Note that this is a heuristic aide and simplified to some degree. It is often desirable to allow for more complex relationships such as allowing lower levels of test to satisfy some high level verification requirements and higher levels of test to satisfy lower level verification requirements where possible and appropriate.
SoftwareCPR provides a variety of design control and software development planning, triaining and hands-on V&V services to help you ensure safety and compliance. Brian has provided training in-house at FDA and was on the standards committee for AAMI TIR45 Guidance on the use of AGILE practices in the development of medical device software.

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John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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