Vios QMS Training: Sdlc Dop

5 Questions | Total Attempts: 42

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Vios QMS Training: Sdlc Dop

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Questions and Answers
  • 1. 
    The Software Development Life Cycle DOP applies to both firmware and software development.
    • A. 

      True

    • B. 

      False

  • 2. 
    Which options satisfy the Software Development Plan requirement? (Check all that apply.)
    • A. 

      A separate Software Development Plan or Firmware Development Plan.

    • B. 

      A Project Plan that contains or references the Software or Firmware Development Plan information.

    • C. 

      A sprint tracker spreadsheet that contains all of the work.

    • D. 

      None of the above.

  • 3. 
    Which options would be considered SOUP? (Check all that apply.)
    • A. 

      Off the shelf libraries

    • B. 

      Development tools such as compilers or Jira

    • C. 

      Outsourced software that does not follow Vios procedure or 62304, but is controlled.

    • D. 

      Internally developed software that does not follow Vios procedure or 62304, but is controlled.

    • E. 

      None of the above.

  • 4. 
    The SDLC DOP is only for new development, not maintenance releases.
    • A. 

      True

    • B. 

      False

  • 5. 
    What is the difference between design verification and design validation?
    • A. 

      Nothing, the terms are interchangeable.

    • B. 

      Design verification is for happy path testing and design validation is for robustness testing.

    • C. 

      Design verification assesses requirements and design validation assesses intended use.

    • D. 

      None of the above.

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