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Question 27 - CTAL-TTA discussion

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You are involved in testing a system in the medical domain. Testing needs to comply with the FDA requirements and is rated as being safety critical. A product risk assessment has been performed and various mitigation actions have been identified. Reliability testing is one of the test types that needs to be performed throughout the development lifecycle.

Based on the information provided, which of the following activities would need to be addressed in the test plan?

A.
Perform a vulnerability scan.
Answers
A.
Perform a vulnerability scan.
B.
Design and execution of specific tests that evaluate the software's tolerance to faults in terms of handling unexpected input values.
Answers
B.
Design and execution of specific tests that evaluate the software's tolerance to faults in terms of handling unexpected input values.
C.
Design and execution of test cases for scalability.
Answers
C.
Design and execution of test cases for scalability.
D.
Testing whether the installation/de-installation can be completed.
Answers
D.
Testing whether the installation/de-installation can be completed.
Suggested answer: B

Explanation:

In the context of safety-critical systems, particularly in the medical domain, reliability is of utmost importance. For such systems, it is crucial to ensure that the software can handle unexpected input values and continue to operate without failure. This is essential to ensure patient safety and compliance with FDA requirements. Vulnerability scans (option A) are more related to security testing, whereas scalability (option C) and installation/de-installation (option D) are important but not specifically related to the reliability and safety criticality of the system in the medical domain.

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asked 18/09/2024
Dubravko Jerkovic
33 questions
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