CRAP Risk Assessment & Management 3

Question 1

Under ICH Q9, which risk management tool is best suited for identifying potential failure modes and their effects in a manufacturing process?

Accepted Answer

Failure Mode and Effects Analysis (FMEA)

Answer

FMEA systematically evaluates each potential failure mode in a process and its effects, making it ideal for manufacturing process risk assessment.

Question 2

A regulatory affairs professional is preparing a 510(k) submission for a Class II device. Which section should include the risk management summary?

Accepted Answer

Performance Testing section

Answer

The performance testing section of a 510(k) typically includes risk management documentation to demonstrate safety and effectiveness relative to the predicate device.

Question 3

In the EU MDR 2017/745, what is the primary document that summarizes risk management outcomes for a medical device?

Accepted Answer

Technical Documentation Risk Management Report

Answer

The Technical Documentation under EU MDR must include a risk management report summarizing the risk management process and residual risks.

Question 4

Which approach best describes 'inherently safe design' as a risk control measure under ISO 14971?

Accepted Answer

Eliminating or reducing hazards through design before applying other controls

Answer

Inherently safe design is the first priority in the risk control hierarchy—eliminating the hazard at its source through design choices.

Question 5

What is a 'use error' in the context of medical device risk management?

Accepted Answer

An action or inaction by a user that produces an unintended result, potentially causing harm

Answer

Use errors arise from human interaction with the device and are a critical focus of human factors and usability engineering in risk management.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP Risk Assessment & Management 3