CPMS CPMS Software Validation & Testing 1

Question 1

Which FDA guidance document specifically addresses software validation for medical devices?

Accepted Answer

General Principles of Software Validation (2002)

Answer

FDA's General Principles of Software Validation (2002) is the primary guidance for validating software used in medical devices.

Question 2

What is the primary purpose of Installation Qualification (IQ) in medical software validation?

Accepted Answer

Confirming the software is installed correctly and meets design specifications

Answer

IQ confirms that the software and its hardware environment are installed correctly and meet defined design specifications before operational testing begins.

Question 3

In medical software validation, which testing phase confirms that the system meets end-user requirements in the actual production environment?

Accepted Answer

User Acceptance Testing (UAT)

Answer

User Acceptance Testing (UAT) validates that the software meets end-user requirements and performs correctly in the actual production environment.

Question 4

Which international standard defines the software development lifecycle requirements for medical device software?

Accepted Answer

IEC 62304:2006/AMD1:2015

Answer

IEC 62304:2006 (amended 2015) defines the lifecycle requirements for medical device software development, maintenance, and risk management.

Question 5

What does a traceability matrix in medical software validation primarily demonstrate?

Accepted Answer

Linkage between user requirements, design specifications, and test cases

Answer

A traceability matrix maps user requirements to design specifications and corresponding test cases, demonstrating complete validation coverage.

(CPMS) Certified Professional for Medical Software Practice Test

(CPMS) Certified Professional for Medical Software Practice Test

CPMS CPMS Software Validation & Testing 1