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  • Roberto Pineda replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices 8 years, 5 months ago

    In personal experience, the design matrix is the most important part of the risk management analysis. The way it was done in a job I had, was by how much money the owner of the company was going to make. He always put pressure on the workers to get things done on time and just have enough quality to pass the tests required by the FDA. It was a small company so everyone knew each other and there was a more close relation with all the workers.