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  • myton replied to the topic Risk Management – Identification in the forum Risk Analysis for Medical Devices 7 years, 4 months ago

    Risk identification is an important aspect of medical device development. It is better to prevent than to fix because fixing implies that damage has been dealt. Risk identification is part of risk identification, which is the mitigation of the potential setbacks or complications that may arise during the development that may potentially cost a lot. Risk identification includes the evaluation of the device and the parts and processes that come with it. To accomplish an effective risk identification, different sectors involved involved in the project must meet together in order to evaluate the risks and benefits that accompany the development. It is important to point out the presence of different perspectives in the meetings because they will provide different points of views that will help in the evaluation of the device. It is important to keep an open and critical mind in order to thoroughly make sure that the device is examined. It would also be a good idea to have outside contractors or actual possible users, come in and evaluate the device in order to have a testimonial on the state of the device. After identification, the risks will then be classified and this is done in order to prioritize which problems must be solved first or which risks can be ignored for the mean time. This is also important because in this point, the developers must do a benefit/risk balance since not all problems can be solved.