CPMS CPMS Risk Management & Quality Assurance

Question 1

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

Accepted Answer

ISO 14971:2019

Answer

ISO 9001:2015

Answer

IEC 62304:2006

Answer

IEC 60601-1

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

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

Answer

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

Answer

Risk control → Residual risk evaluation → Risk analysis → 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 software defect that has already caused patient harm

Answer

A regulatory violation identified during an audit

Answer

A failed test case in the validation protocol

Question 4

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

Accepted Answer

Failure Modes and Effects Analysis

Answer

Functional Medical Error Analysis

Answer

Formal Medical Equipment Assessment

Answer

Fault Management and Error Avoidance

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

To store employee training records for device development staff

Answer

To list all regulatory submissions made for the device

Answer

To document customer complaints related to the device

Question 6

Which risk control measure has the highest priority according to ISO 14971?

Accepted Answer

Inherent safety by design

Answer

Information for safety (warnings and labels)

Answer

Protective measures in the device or manufacturing process

Answer

User training and instructions