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.
Read the first 7 Software Lifecycle Management flashcards as text
Which international standard specifically defines lifecycle requirements for medical device software development and maintenance?
Answer: IEC 62304
IEC 62304 is the international standard that defines software lifecycle processes specifically for medical device software, covering development through maintenance.
In IEC 62304, which software safety class applies when software failure could result in death or serious injury, requiring the most rigorous development processes?
Answer: Class C
IEC 62304 Class C applies when software failure could directly cause death or serious injury, mandating the highest level of rigor including unit testing, integration testing, and full traceability.
What is the primary purpose of a Software Requirements Specification (SRS) in the medical software lifecycle?
Answer: To define what the software must do and the conditions under which it must perform
The SRS defines the functional and non-functional requirements the software must satisfy, serving as the baseline for design, development, and verification activities.
During which phase of the software development lifecycle are individual software modules combined and tested together to verify they function correctly as a whole?
Answer: Integration and integration testing phase
Integration and integration testing is the phase where individual modules are combined and tested together to confirm they work correctly as an assembled system before system-level testing.
What is the primary purpose of software configuration management (SCM) in medical device software development?
Answer: To control and track changes to software items throughout the lifecycle
Software configuration management ensures all software items and changes are systematically identified, controlled, and tracked, enabling reproducibility and audit traceability throughout the lifecycle.
What is the primary purpose of a software detailed design document in medical device software development?
Answer: To specify how each software unit will be implemented, including algorithms and data structures
The software detailed design document specifies how each software unit will be implemented, providing enough detail for developers to write code and for reviewers to verify correctness.
Which lifecycle activity confirms that medical device software meets the needs of its intended users in the intended use environment?
Answer: Software validation
Software validation confirms the software meets user needs in the intended use environment, answering 'Are we building the right product?' as opposed to verification which checks against specifications.