What is the primary purpose of ISO 14971 in medical device risk management?

• A. To provide a systematic process for identifying hazards, estimating and evaluating risks, controlling risk, and monitoring the effectiveness of risk controls throughout a device's life cycle.
• B. To specify requirements for labeling and advertising medical devices.
• C. To outline clinical trial design for medical devices.
• D. To define electrical safety standards for medical equipment.

Answer: (A)

ISO 14971 provides a systematic risk management process for medical devices that guides teams to identify hazards, analyze and evaluate the associated risks (considering both likelihood and severity), implement risk controls to reduce those risks, and verify that the controls are effective, all across the device’s life cycle and within the documented risk management file. This keeps risk assessment ongoing—from design through production, use, and post-market monitoring—so any new hazards or changes in context can be addressed. The standard isn’t about labeling and advertising, clinical trial design, or electrical safety standards; those areas are governed by other, more specific requirements.