CPMS Medical Software Development & Integration 3

Question 1

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

Accepted Answer

Identify software-related causes of hazardous situations

Answer

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?

Accepted Answer

Storage SOP Class

Answer

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)?

Accepted Answer

FDA Guidance on Software as a Medical Device (2019)

Answer

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?

Accepted Answer

POST

Answer

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?

Accepted Answer

Linking requirements to design, implementation, and test artifacts

Answer

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

(CPMS) Certified Professional for Medical Software Practice Test