CPMS Medical Software Development & Integration 3 — Questions and Answers
Question 1: What is the primary purpose of a 'software hazard analysis' in medical device development?
- Estimate project cost
- Identify software-related causes of hazardous situations (Correct answer)
- Audit source code for style issues
- Track developer productivity
Correct 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.
Question 2: In DICOM networking, which service class is used to move image data from one device to another?
- Verification SOP Class
- Storage SOP Class (Correct answer)
- Query/Retrieve SOP Class
- Worklist Management SOP Class
Correct answer: Storage SOP Class
The DICOM Storage SOP Class (C-STORE) is used to transfer image objects from one device (SCU) to another (SCP).
Question 3: Which FDA guidance document specifically addresses the content of premarket submissions for software as a medical device (SaMD)?
- 21 CFR Part 11
- FDA Guidance on Software as a Medical Device (2019) (Correct answer)
- ISO 27001
- HIPAA Privacy Rule
Correct 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.
Question 4: In a FHIR RESTful API, which HTTP method is used to create a new resource on the server?
- GET
- PUT
- POST (Correct answer)
- DELETE
Correct answer: POST
HTTP POST is used in FHIR to create a new resource when the server assigns the resource ID.
Question 5: What does 'traceability' mean in the context of medical software development?
- The ability to log all user actions in an audit trail
- Linking requirements to design, implementation, and test artifacts (Correct answer)
- Tracking device location in a hospital
- Monitoring software performance in production
Correct 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.
Question 6: Which standard governs the application of risk management principles specifically for medical devices, including software?
- ISO 9001
- ISO 14971 (Correct answer)
- IEC 60601
- IEEE 830
Correct answer: ISO 14971
ISO 14971 specifies the process for risk management of medical devices, including the software components within them.
Question 7: When performing a gap analysis between two HL7 FHIR implementation guides, what is the developer primarily evaluating?
- Network latency between servers
- Differences in supported resources, profiles, and must-support elements (Correct answer)
- Database schema compatibility
- User interface design consistency
Correct 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.
CPMS Medical Software Development & Integration 3
What is the primary purpose of a 'software hazard analysis' in medical device development?