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About Risk Management For Medical Devices


ISO 14971 defines risk as the “combination of the probability of occurrence of harm and the severity of that harm. Risk management for medical devices is “the systematic application of management policies, procedures and practices, to the tasks of analyzing, evaluating, monitoring and controlling risk.


It’s important to note that severity is a key component of risk management. Many people erroneously assume that risk is purely a percentage. If 1 of every 1,000 people dies due to a faulty pacemaker, for example, that’s a more severe “risk” than having 1 of every 300 who might suffer minor burns due to poor design of an electrical component of a medical device.


Risk management consists of two parts: risk analysis and risk evaluation. This applies to all phases of the device lifecycle, including planning/product realization, design and development, purchasing, service and change control. Types of hazards that need to be evaluated include energy, biological, environmental, software, user error, labeling, complexity of use and functional failure hazards. After risk assessment and evaluation , we must create a plan of attack for monitoring and controlling those identified risks.


Medical Device risk management is a not a one-time project. It is an ongoing process of review and risk assessment throughout the life of the device. Companies that take the process seriously will reap the rewards of fewer defects, increased user safety and, in some cases, reduced risk of litigation. Post-market surveillance and vigilance (alert watchfulness) are key tools in this process.


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