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Medical Software Development & Integration Flashcards

7 cards from real CPMS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Medical Software Development & Integration flashcards as text

  1. What does the term 'regression testing' specifically address in iterative medical software development?

    Answer: Verifying that new changes have not broken previously working functionality

    Regression testing ensures that changes, bug fixes, or new features have not introduced defects into previously verified functionality.

  2. In FHIR, what is a 'Capability Statement' used for?

    Answer: Describing the capabilities of a FHIR server, including supported resources and interactions

    A FHIR CapabilityStatement resource declares what resources, operations, and search parameters a server supports, enabling interoperability discovery.

  3. Which security threat model is most relevant when designing a medical device API that accepts data from external partners?

    Answer: STRIDE

    STRIDE (Spoofing, Tampering, Repudiation, Information Disclosure, DoS, Elevation of Privilege) is the standard threat modeling framework used for identifying security risks in software systems.

  4. When documenting software architecture for a Class C medical device under IEC 62304, which artifact is explicitly required?

    Answer: Software architecture specification identifying software items and their interfaces

    IEC 62304 requires a documented software architecture that identifies all software items and their interfaces for Class B and C devices.

  5. Which approach best supports continuous compliance in an agile medical software development team?

    Answer: Embedding risk management and documentation tasks into each sprint's definition of done

    Embedding compliance activities (risk updates, traceability, documentation) into the sprint definition of done ensures ongoing regulatory readiness without a last-minute scramble.

  6. In a DICOM WADO (Web Access to DICOM Objects) service, what is the primary function?

    Answer: Retrieve DICOM objects using web-based HTTP requests

    WADO (Web Access to DICOM Objects) enables retrieval of DICOM instances via standard HTTP/HTTPS requests, making images accessible to web-based viewers.

  7. What is the significance of a 'change control process' in post-market medical software maintenance per IEC 62304?

    Answer: It ensures that modifications are evaluated for impact on safety, risk, and regulatory status before implementation

    Change control requires that every modification be assessed for its effect on safety classification, risk profile, and regulatory documentation before the change is made.