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

Software that is more than ten years old

Answer

Software that is no longer commercially supported by its original vendor

Answer

Software developed before IEC 62304 was published in 2006

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

Software Requirements Specification

Answer

Software Detailed Design Document

Answer

Software Validation Plan

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

Only when a complete rewrite of the software system is undertaken

Answer

Only during the initial software validation phase prior to first release

Answer

Whenever new regulatory guidance documents are published by the FDA

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

Only when a completely new device model is commercially released

Answer

Only when the software's original regulatory clearance or approval expires

Answer

When a competing product with new or superior features enters the market

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

To market the approved software to healthcare providers and end users

Answer

To train clinical staff on new software features before deployment

Answer

To archive software source code in a secure long-term repository

Question 6

Why is maintaining version control throughout the medical software lifecycle significant?

Accepted Answer

It ensures reproducibility and enables accurate problem investigation and regulatory submissions

Answer

It allows developers to permanently delete old versions that are no longer in use

Answer

It primarily serves as a marketing tool to demonstrate a product's development history

Answer

It is required only for Class C software under IEC 62304 and optional otherwise

Question 7

What is the role of a software maintenance plan in the medical device software lifecycle?

Accepted Answer

A plan defining processes for managing and implementing changes after software release

Answer

A document describing planned software updates for regulatory marketing submissions

Answer

A schedule for routine software deletion and replacement with newer versions

Answer

A guide for training end users on how to operate software updates