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

SOUP (Software of Unknown Provenance) refers to software items not developed under a known software development lifecycle, including commercial off-the-shelf and open-source software.

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

Change control must be initiated for any proposed modification to released software so that changes are formally evaluated, documented, and approved before implementation.

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

A traceability matrix links requirements to design elements, source code, and test cases, ensuring complete coverage and enabling impact analysis when changes occur.

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 confirms software meets specified requirements ('Are we building it right?') while validation confirms the product meets user needs in the intended environment ('Are we building the right product?').

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 B applies when software failure can contribute to a hazardous situation, but additional non-software risk controls mitigate serious injury, requiring more rigor than Class A but less than Class C.

(CPMS) Certified Professional for Medical Software Practice Test

(CPMS) Certified Professional for Medical Software Practice Test

CPMS Software Lifecycle Management 2