CPMS Medical Software Development & Integration 4

Question 1

What is the key difference between 'verification' and 'validation' in medical software development?

Accepted Answer

Verification confirms the software is built correctly; validation confirms it is the right software for its intended use

Answer

Verification ensures the software meets its specified requirements, while validation ensures the software fulfills its intended use in the clinical environment.

Question 2

In the context of clinical decision support (CDS) software, which FDA framework level describes software that provides patient-specific information requiring clinician interpretation?

Accepted Answer

Non-Device CDS

Answer

Non-Device CDS under the FDA 21st Century Cures Act framework includes software that displays information to clinicians who must independently review and act on it.

Question 3

Which type of software anomaly in IEC 62304 must always be investigated and resolved before software release?

Accepted Answer

Anomalies with unacceptable residual risk

Answer

IEC 62304 requires that software anomalies that could result in unacceptable risk must be resolved or mitigated before release.

Question 4

In DICOM, what is the role of the 'Modality Worklist' service?

Accepted Answer

Provide imaging devices with scheduled procedure information from an order system

Answer

DICOM Modality Worklist allows imaging modalities to query for scheduled procedures, reducing manual data entry and transcription errors.

Question 5

Which integration architecture pattern is most appropriate for real-time patient monitoring data streaming from a bedside device to a clinical system?

Accepted Answer

Publish-subscribe messaging with a broker (e.g., MQTT or AMQP)

Answer

Publish-subscribe messaging enables real-time, low-latency delivery of monitoring data from devices to consuming systems without tight coupling.

(CPMS) Certified Professional for Medical Software Practice Test

(CPMS) Certified Professional for Medical Software Practice Test

CPMS Medical Software Development & Integration 4