CPMS Medical Software Development & Integration 4 — Questions and Answers
Question 1: What is the key difference between 'verification' and 'validation' in medical software development?
- Verification is done by users; validation by developers
- Verification confirms the software is built correctly; validation confirms it is the right software for its intended use (Correct answer)
- Verification is post-market; validation is pre-market
- There is no meaningful difference between the two
Correct answer: Verification confirms the software is built correctly; validation confirms it is the right software for its intended use
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?
- Non-Device CDS (Correct answer)
- Device CDS
- Class I Device
- Class III Device
Correct answer: Non-Device CDS
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?
- All known anomalies regardless of severity
- Anomalies with unacceptable residual risk (Correct answer)
- Minor UI cosmetic defects
- Performance degradation under extreme load
Correct answer: Anomalies with unacceptable residual risk
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?
- Store completed studies to a PACS
- Provide imaging devices with scheduled procedure information from an order system (Correct answer)
- Anonymize patient data for research
- Route reports to referring physicians
Correct answer: Provide imaging devices with scheduled procedure information from an order system
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?
- Batch file transfer via SFTP
- Publish-subscribe messaging with a broker (e.g., MQTT or AMQP) (Correct answer)
- Manual data entry by nursing staff
- Periodic database polling every 15 minutes
Correct answer: Publish-subscribe messaging with a broker (e.g., MQTT or AMQP)
Publish-subscribe messaging enables real-time, low-latency delivery of monitoring data from devices to consuming systems without tight coupling.
Question 6: What is a 'software item' as defined in IEC 62304?
- Any hardware component of a medical device
- Any identifiable part of a software system, including units, components, and systems (Correct answer)
- A regulatory submission artifact
- A compiled executable binary only
Correct answer: Any identifiable part of a software system, including units, components, and systems
IEC 62304 defines a software item as any identifiable part of a software system, which can be decomposed into software units, components, and systems.
Question 7: Under 21 CFR Part 11, which of the following is required for an electronic signature to be considered legally binding for medical records?
- A scanned image of a handwritten signature
- A printed name and date typed into a text field
- A unique combination of identification components (e.g., username + password) with a manifest linking the signature to the record (Correct answer)
- Any digital image attached to a document
Correct answer: A unique combination of identification components (e.g., username + password) with a manifest linking the signature to the record
21 CFR Part 11 requires electronic signatures to consist of at least two distinct components and be linked to their associated electronic records to be legally binding.
CPMS Medical Software Development & Integration 4
What is the key difference between 'verification' and 'validation' in medical software development?