CPMS CPMS Software Validation & Testing

Question 1

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

Accepted Answer

General Principles of Software Validation (2002)

Answer

21 CFR Part 11

Answer

ISO 13485:2016

Answer

IEC 62304:2006

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

Verifying the software performs as intended under real-world conditions

Answer

Testing user workflows against operational requirements

Answer

Documenting software defects found during acceptance testing

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

Unit testing

Answer

Integration testing

Answer

Regression testing

Question 4

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

Accepted Answer

IEC 62304:2006/AMD1:2015

Answer

ISO 9001:2015

Answer

ISO 14971:2019

Answer

IEEE 829

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

The timeline of the validation project

Answer

The hierarchy of software development team roles

Answer

Defect density across software modules

Question 6

During Operational Qualification (OQ) of medical software, what is being primarily verified?

Accepted Answer

That the software performs as intended across its operating range

Answer

That the software is installed in the correct environment

Answer

That the software meets user needs in production

Answer

That the software source code is free of vulnerabilities