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

ISO 13485

Answer

FDA 21 CFR Part 11

Answer

ISO 14971

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

Class A

Answer

Class B

Answer

Class D

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

To document test cases for software validation

Answer

To describe the software architecture and component interactions

Answer

To outline the post-market surveillance plan

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

Requirements phase

Answer

Architectural design phase

Answer

System testing phase

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

To manage the software user interface design standards

Answer

To document clinical trial results associated with the software

Answer

To manage software licensing and intellectual property rights

Question 6

What is the primary purpose of a software detailed design document in medical device software development?

Accepted Answer

To specify how each software unit will be implemented, including algorithms and data structures

Answer

To describe how the software will be marketed to end users

Answer

To outline the training requirements for clinical staff

Answer

To document the results of usability testing sessions

Question 7

Which lifecycle activity confirms that medical device software meets the needs of its intended users in the intended use environment?

Accepted Answer

Software validation

Answer

Software verification

Answer

Software integration testing

Answer

Software unit testing