CPMS Software Lifecycle Management 1 — Questions and Answers
Question 1: Which international standard specifically defines lifecycle requirements for medical device software development and maintenance?
- ISO 13485
- IEC 62304 (Correct answer)
- FDA 21 CFR Part 11
- ISO 14971
Correct answer: IEC 62304
IEC 62304 is the international standard that defines software lifecycle processes specifically for medical device software, covering development through maintenance.
Question 2: In IEC 62304, which software safety class applies when software failure could result in death or serious injury, requiring the most rigorous development processes?
- Class A
- Class B
- Class C (Correct answer)
- Class D
Correct 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.
Question 3: What is the primary purpose of a Software Requirements Specification (SRS) in the medical software lifecycle?
- To document test cases for software validation
- To define what the software must do and the conditions under which it must perform (Correct answer)
- To describe the software architecture and component interactions
- To outline the post-market surveillance plan
Correct 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.
Question 4: During which phase of the software development lifecycle are individual software modules combined and tested together to verify they function correctly as a whole?
- Requirements phase
- Architectural design phase
- Integration and integration testing phase (Correct answer)
- System testing phase
Correct 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.
Question 5: What is the primary purpose of software configuration management (SCM) in medical device software development?
- To manage the software user interface design standards
- To control and track changes to software items throughout the lifecycle (Correct answer)
- To document clinical trial results associated with the software
- To manage software licensing and intellectual property rights
Correct 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.
Question 6: What is the primary purpose of a software detailed design document in medical device software development?
- To describe how the software will be marketed to end users
- To outline the training requirements for clinical staff
- To specify how each software unit will be implemented, including algorithms and data structures (Correct answer)
- To document the results of usability testing sessions
Correct 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.
Question 7: Which lifecycle activity confirms that medical device software meets the needs of its intended users in the intended use environment?
- Software verification
- Software validation (Correct answer)
- Software integration testing
- Software unit testing
Correct 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.
CPMS Software Lifecycle Management 1
Which international standard specifically defines lifecycle requirements for medical device software development and maintenance?