CPMS Software Lifecycle Management

Question 1

Which international standard specifically defines lifecycle requirements for medical device software development and maintenance?

Accepted Answer

IEC 62304

Answer

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?

Accepted Answer

Class C

Answer

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?

Accepted Answer

To define what the software must do and the conditions under which it must perform

Answer

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?

Accepted Answer

Integration and integration testing phase

Answer

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?

Accepted Answer

To control and track changes to software items throughout the lifecycle

Answer

Software configuration management ensures all software items and changes are systematically identified, controlled, and tracked, enabling reproducibility and audit traceability throughout the lifecycle.

(CPMS) Certified Professional for Medical Software Practice Test

(CPMS) Certified Professional for Medical Software Practice Test

CPMS Software Lifecycle Management