CPMS Risk Management & Quality Assurance Flashcards
6 cards from real CPMS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CPMS Risk Management & Quality Assurance flashcards as text
Which international standard provides a framework for risk management of medical devices, including software?
Answer: ISO 14971:2019
ISO 14971:2019 is the internationally recognized standard for applying risk management principles throughout the medical device lifecycle, including software.
In ISO 14971 risk management, what is the correct sequence of the risk management process?
Answer: Risk analysis → Risk evaluation → Risk control → Residual risk evaluation
ISO 14971 defines the sequence as: risk analysis, then risk evaluation, followed by risk control, and finally residual risk evaluation.
What is a 'hazardous situation' as defined in ISO 14971?
Answer: A circumstance in which people, property, or the environment are exposed to one or more hazards
A hazardous situation is defined as a circumstance in which people, property, or the environment are exposed to one or more hazards.
In medical software risk management, what does the acronym FMEA stand for?
Answer: Failure Modes and Effects Analysis
FMEA stands for Failure Modes and Effects Analysis, a systematic method for identifying potential failure modes and their effects on system performance and safety.
What is the purpose of a Risk Management File under ISO 14971?
Answer: To provide a comprehensive repository of all risk management activities and records for a device
The Risk Management File is a comprehensive repository containing all risk management plans, analyses, evaluations, and reports for a medical device.
Which risk control measure has the highest priority according to ISO 14971?
Answer: Inherent safety by design
ISO 14971 establishes inherent safety by design as the highest-priority risk control measure, followed by protective measures, then information for safety.