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Regulatory Focus™ > News Articles > Applying Risk/Benefit Considerations Across a Quality Management System

Applying Risk/Benefit Considerations Across a Quality Management System

Posted 01 December 2009

Risk management activities should not be limited to the design control phase of a device. In fact, risk/benefit assessment should be a proactive activity throughout the device lifecycle to ensure that known risks remain acceptable and any new or unknown risks can be analyzed and mitigated. Applying risk management principles and activities in various subsystems within a quality management system is a prudent approach in identifying and addressing safety issues. This article provides practical explanations and examples of how this can be achieved, based on recommendations in harmonized standards such as those developed by the Global Harmonization Task Force (GHTF)1 and International Organization for Standardization (ISO).1,2 In general, risk/benefit can be managed in four phases, namely: identifying attendant risks; analyzing risks; estimating risks compared to risk acceptability criteria; and risk mitigation and monitoring.

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