CPMS Software Lifecycle Management 2

Question 1

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

Accepted Answer

Software of Unknown Provenance

Answer

Software of Unified Purpose

Answer

Structured Output Unit Protocol

Answer

System of Unverified Processes

Question 2

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

Accepted Answer

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

Answer

Only when the device is subject to a regulatory recall

Answer

Only during the initial software development and design phase

Answer

Only when a new commercial software version is publicly launched

Question 3

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

Accepted Answer

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

Answer

To track software development project timelines and resource allocation

Answer

To document the software's network architecture and communication protocols

Answer

To record all software defects and their resolution status

Question 4

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

Accepted Answer

Verification checks outputs against specifications; validation checks against user needs

Answer

Verification occurs after validation in the development sequence

Answer

Verification is performed by users in clinical settings; validation is performed by developers

Answer

Verification applies only to hardware interfaces; validation applies only to software functions

Question 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?

Accepted Answer

Class B

Answer

Class A

Answer

Class C

Answer

Class D

Question 6

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

Accepted Answer

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

Answer

To document new feature requests submitted by clinical users

Answer

To report quarterly software performance metrics to management

Answer

To document software training completion records for regulatory compliance

Question 7

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

Accepted Answer

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

Answer

Any physical hardware component that executes software instructions

Answer

Only the compiled executable files shipped as part of a medical device

Answer

The complete finished software product approved for market release