CPMS CPMS Risk Management & Quality Assurance 1 — Questions and Answers
Question 1: Which international standard provides a framework for risk management of medical devices, including software?
- ISO 9001:2015
- IEC 62304:2006
- ISO 14971:2019 (Correct answer)
- IEC 60601-1
Correct answer: ISO 14971:2019
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?
- Risk control → Risk analysis → Risk evaluation → Residual risk evaluation
- Risk analysis → Risk evaluation → Risk control → Residual risk evaluation (Correct answer)
- Risk evaluation → Risk control → Risk analysis → Residual risk evaluation
- Risk control → Residual risk evaluation → Risk analysis → Risk evaluation
Correct 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.
Question 3: What is a 'hazardous situation' as defined in ISO 14971?
- A software defect that has already caused patient harm
- A circumstance in which people, property, or the environment are exposed to one or more hazards (Correct answer)
- A regulatory violation identified during an audit
- A failed test case in the validation protocol
Correct 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.
Question 4: In medical software risk management, what does the acronym FMEA stand for?
- Functional Medical Error Analysis
- Failure Modes and Effects Analysis (Correct answer)
- Formal Medical Equipment Assessment
- Fault Management and Error Avoidance
Correct 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.
Question 5: What is the purpose of a Risk Management File under ISO 14971?
- To store employee training records for device development staff
- To provide a comprehensive repository of all risk management activities and records for a device (Correct answer)
- To list all regulatory submissions made for the device
- To document customer complaints related to the device
Correct 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.
Question 6: Which risk control measure has the highest priority according to ISO 14971?
- Information for safety (warnings and labels)
- Protective measures in the device or manufacturing process
- Inherent safety by design (Correct answer)
- User training and instructions
Correct 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.
CPMS CPMS Risk Management & Quality Assurance 1
Which international standard provides a framework for risk management of medical devices, including software?