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krp76 replied to the topic How to run a risk management meeting ? in the forum Risk Analysis for Medical Devices 7 years, 4 months ago
The best strategy in running risk management meetings is to ensure understanding of the device. A basic understanding of the device components, it’s functionality, and how the end user will be utilizing the device are all key in recognizing risks associated with the device. From the initial meeting onward a running list of potential risks should be updated at meetings and quality should be responsible in assessing any risks that are presented. Prior to conducting any trials there should be a comprehensive list of potential risks and the severity of those risks and strategies in neutralizing the risk would be discussed with the project team.