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hzy2 replied to the topic Discussion Topic: Risk Management, Risk Analysis in the forum Risk Analysis for Medical Devices 6 years, 4 months ago
Medical device companies are required to have an established risk management process in compliance with ISO14971. This process includes identifying hazardous situations that may come up with the medical device being developed, evaluation of these hazardous situations, ways in which these situations can be controlled or avoided and monitoring the effectiveness of the actions taken to avoid these risks. All of this aims to provide good quality service and products to the people who will need these devices as their safety is a major concern.