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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 is the primary purpose of a 'software hazard analysis' in medical device development?

    Answer: Identify software-related causes of hazardous situations

    Software hazard analysis identifies how software failures or anomalies can contribute to hazardous situations that affect patient safety.

  2. In DICOM networking, which service class is used to move image data from one device to another?

    Answer: Storage SOP Class

    The DICOM Storage SOP Class (C-STORE) is used to transfer image objects from one device (SCU) to another (SCP).

  3. Which FDA guidance document specifically addresses the content of premarket submissions for software as a medical device (SaMD)?

    Answer: FDA Guidance on Software as a Medical Device (2019)

    The 2019 FDA guidance on Software as a Medical Device outlines what manufacturers must submit in premarket applications for SaMD.

  4. In a FHIR RESTful API, which HTTP method is used to create a new resource on the server?

    Answer: POST

    HTTP POST is used in FHIR to create a new resource when the server assigns the resource ID.

  5. What does 'traceability' mean in the context of medical software development?

    Answer: Linking requirements to design, implementation, and test artifacts

    Traceability in software development means each requirement can be traced forward to its design implementation and backward to its test evidence.

  6. Which standard governs the application of risk management principles specifically for medical devices, including software?

    Answer: ISO 14971

    ISO 14971 specifies the process for risk management of medical devices, including the software components within them.

  7. When performing a gap analysis between two HL7 FHIR implementation guides, what is the developer primarily evaluating?

    Answer: Differences in supported resources, profiles, and must-support elements

    A gap analysis between FHIR implementation guides identifies missing resources, profile mismatches, and unsupported must-support elements that need to be addressed for interoperability.