Software Testing Regulatory Frameworks & Compliance 4

Question 1

A tester working on a medical device must ensure software meets ISO 14971 requirements. What does this standard primarily address?

Accepted Answer

Risk management for medical devices

Answer

ISO 14971 is the international standard for risk management of medical devices, requiring identification, evaluation, and control of risks throughout the software lifecycle.

Question 2

Under NIST SP 800-53, which testing activity satisfies the 'CA-8' control for penetration testing of federal information systems?

Accepted Answer

Conducting authorized simulated attacks to identify exploitable vulnerabilities

Answer

NIST SP 800-53 CA-8 requires organizations to conduct penetration testing to identify weaknesses that could be exploited by adversaries.

Question 3

What distinguishes 'qualification testing' from standard system testing in aerospace and defense software contexts?

Accepted Answer

Qualification testing demonstrates the software meets its stated requirements for regulatory approval

Answer

Qualification testing provides formal, documented evidence that software meets specified requirements for regulatory or contractual approval, not just internal quality checks.

Question 4

In SOC 2 (Service Organization Control 2) compliance, which testing validates the 'Availability' trust service criterion?

Accepted Answer

Testing that systems meet agreed-upon uptime commitments and recovery objectives

Answer

SOC 2 Availability testing verifies that systems are operational and accessible as committed, typically through uptime measurement and disaster recovery testing.

Question 5

Which testing challenge is MOST unique to compliance testing compared to standard functional testing?

Accepted Answer

Providing legally defensible documentation that requirements were met

Answer

Compliance testing must produce auditable, legally defensible evidence that regulatory requirements were verified, not just confirm the software works.

Software Testing Practice Test

Software Testing Practice Test

Software Testing Regulatory Frameworks & Compliance 4