CPMS CPMS Risk Management & Quality Assurance 1

Question 1

Which international standard provides a framework for risk management of medical devices, including software?

Accepted Answer

ISO 14971:2019

Answer

ISO 14971:2019 is the internationally recognized standard for applying risk management principles throughout the medical device lifecycle, including software.

Question 2

In ISO 14971 risk management, what is the correct sequence of the risk management process?

Accepted Answer

Risk analysis → Risk evaluation → Risk control → Residual risk evaluation

Answer

ISO 14971 defines the sequence as: risk analysis, then risk evaluation, followed by risk control, and finally residual risk evaluation.

Question 3

What is a 'hazardous situation' as defined in ISO 14971?

Accepted Answer

A circumstance in which people, property, or the environment are exposed to one or more hazards

Answer

A hazardous situation is defined as a circumstance in which people, property, or the environment are exposed to one or more hazards.

Question 4

In medical software risk management, what does the acronym FMEA stand for?

Accepted Answer

Failure Modes and Effects Analysis

Answer

FMEA stands for Failure Modes and Effects Analysis, a systematic method for identifying potential failure modes and their effects on system performance and safety.

Question 5

What is the purpose of a Risk Management File under ISO 14971?

Accepted Answer

To provide a comprehensive repository of all risk management activities and records for a device

Answer

The Risk Management File is a comprehensive repository containing all risk management plans, analyses, evaluations, and reports for a medical device.

(CPMS) Certified Professional for Medical Software Practice Test

(CPMS) Certified Professional for Medical Software Practice Test

CPMS CPMS Risk Management & Quality Assurance 1