![]() Risk matrices are typically organized with "Failure Mode Likelihood" on the Y-axis and "Failure Mode Consequences" on the X-axis. Once engineers have assessed the likelihood of a particular failure mode occurring and worked to understand the potential consequences of such a failure, a risk matrix can be used to quantify the risk and determine whether it is justified by the benefits of the device. ![]() Building The Risk Matrix: Risk Likelihood And ConsequencesĪ risk matrix is used to assign a relative descriptor of "high risk," "medium risk" or "low risk" to a specific failure mode depending on its likelihood and consequences. The product of these two scores is used as a relative measure of risk for that particular hazard. (We explain this in depth here, using the grossest example ever! )Įach hazard is assigned a score between 1 and 5 for its severity (consequences) and probability (likelihood that the failure mode would occur). Risk = Severity of Harm (S) x Probability of Occurrence of Harm (POH). Risk can be quantified with the following formula: ![]() A benefit-risk analysis takes the probability of occurrence of HARM and the consequences of that harm and justifies those based on the overall benefit of the medical device for the end user. When medical device engineers design a new medical device, a benefit-risk analysis must be conducted to accurately assess the risk posed by the medical device. Medical Device Engineers Use Benefit-Risk Analysis To Quantify Risk The international standard for risk management in medical device manufacturing is known as ISO 14971.įREE DOWNLOAD: Click here to download our Risk Management Plan Template for medical device companies. Risk matrices are used in conjunction with other tools like benefit- risk analysis to quantify risk, map potential sources of harm to corresponding design features and make decisions about how to reduce the risk of a device. Whether your medical device company intends to sell devices in Europe, Canada, the United States, or all of the above, risk assessment and management will play an important role in your product development activities and the overall planning of your quality management activities and to-market strategy.Ī risk matrix is a tool that medical device designers and engineers can use to assess the risk associated with a specific type of incident. Risk matrices are useful because they offer a standardized criteria and consistent methodology for assessing the risk of medical devices and classifying them appropriately. A risk matrix is a tool used by medical device engineers to quantify the risk level associated with a medical device.
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