CPMS Medical Software Development & Integration 2

Question 1

Which IEC 62304 software safety class requires the most rigorous development and maintenance processes?

Accepted Answer

Class C

Answer

IEC 62304 Class C applies to software where a failure could result in death or serious injury, requiring the highest level of rigor.

Question 2

In HL7 FHIR, what is the primary purpose of a 'Bundle' resource?

Accepted Answer

Group multiple resources into a single transaction or message

Answer

A FHIR Bundle groups multiple resources together, enabling batch operations, transactions, and document assembly.

Question 3

What is 'software of unknown provenance' (SOUP) in the context of IEC 62304?

Accepted Answer

Pre-existing software not developed under a quality system for the current device

Answer

SOUP refers to software items used in medical device software that were not developed under a quality system specifically for the device being developed.

Question 4

Which cryptographic standard is recommended for protecting ePHI in transit under HIPAA Security Rule guidance?

Accepted Answer

TLS 1.2 or higher

Answer

TLS 1.2 or higher is the current recommended standard for encrypting ePHI in transit, as older protocols are considered insecure.

Question 5

In a risk-based testing approach for medical software, what determines the depth of testing for a given module?

Accepted Answer

The software's safety classification and associated risk

Answer

Risk-based testing prioritizes test depth based on the software's safety class and the severity of potential failures.

(CPMS) Certified Professional for Medical Software Practice Test

(CPMS) Certified Professional for Medical Software Practice Test

CPMS Medical Software Development & Integration 2