CPMS Software Lifecycle Management 3

Question 1

How does IEC 62304 define 'legacy software'?

Accepted Answer

Software developed without a documented lifecycle process that must be evaluated and assigned a safety class

Answer

IEC 62304 defines legacy software as software developed prior to adoption of the standard or without a documented development lifecycle that must be evaluated, classified, and brought into conformance.

Question 2

Which document in the medical software lifecycle describes the high-level structure of the system and how major components interact?

Accepted Answer

Software Architecture Document

Answer

The Software Architecture Document describes the high-level structure of the system, identifying major software items and their interfaces, providing the blueprint for detailed design and implementation.

Question 3

When must software regression testing be performed in medical device software development?

Accepted Answer

After any software modification to ensure previously functioning capabilities are not broken

Answer

Regression testing must be performed after any software modification to verify that changes have not inadvertently introduced defects or disrupted previously validated functionality.

Question 4

What triggers the requirement for re-validation of medical device software?

Accepted Answer

Any significant change that could affect the safety or effectiveness of the software

Answer

Re-validation is required for any significant change that could affect software safety or effectiveness, including changes to functionality, operating environment, or hardware platform.

Question 5

What is the primary purpose of a formal software release process in medical device development?

Accepted Answer

To ensure a controlled, documented transition of software from development to production

Answer

The software release process ensures software transitions from development to production in a controlled and documented manner, verifying all lifecycle activities are complete before clinical deployment.

(CPMS) Certified Professional for Medical Software Practice Test

(CPMS) Certified Professional for Medical Software Practice Test

CPMS Software Lifecycle Management 3