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Software Lifecycle Management Flashcards

7 cards from real CPMS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

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  1. What does 'SOUP' stand for in the context of IEC 62304 medical device software?

    Answer: Software of Unknown Provenance

    SOUP (Software of Unknown Provenance) refers to software items not developed under a known software development lifecycle, including commercial off-the-shelf and open-source software.

  2. When should a software change control process be initiated in medical device software?

    Answer: Whenever a modification to released software is proposed, regardless of perceived impact

    Change control must be initiated for any proposed modification to released software so that changes are formally evaluated, documented, and approved before implementation.

  3. What is the purpose of a software traceability matrix in the medical software lifecycle?

    Answer: To map software requirements to design elements, test cases, and code modules

    A traceability matrix links requirements to design elements, source code, and test cases, ensuring complete coverage and enabling impact analysis when changes occur.

  4. What distinguishes software verification from software validation in the medical software lifecycle?

    Answer: Verification checks outputs against specifications; validation checks against user needs

    Verification confirms software meets specified requirements ('Are we building it right?') while validation confirms the product meets user needs in the intended environment ('Are we building the right product?').

  5. In IEC 62304, which software safety class applies when a software failure could contribute to a hazardous situation but other risk controls exist to prevent serious harm?

    Answer: Class B

    Class B applies when software failure can contribute to a hazardous situation, but additional non-software risk controls mitigate serious injury, requiring more rigor than Class A but less than Class C.

  6. What is the purpose of a software problem report (SPR) in medical device software maintenance?

    Answer: To formally record, track, and manage software defects and anomalies

    Software problem reports formally document defects and anomalies discovered during testing or post-release, enabling systematic tracking, investigation, and resolution.

  7. What is a 'software item' as defined in IEC 62304?

    Answer: Any identifiable part of a computer program including source code, object code, and data

    IEC 62304 broadly defines a software item as any identifiable part of a computer program, from a complete software system down to a single module, including source code, object code, and data.