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mmd55 replied to the topic "Customer Needs, Business Requirements, Test Plan" – 3 years, 5 months ago
Posted by: @jtl27 This week’s discussion reminds me a lot of what we had to learn in our capstone design class senior year. The three biggest deliverables for that class other than our powerpoint presentations were the two documents that… Read more»
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thuytienlecao replied to the topic "Discussion Topic: Risk Management, Risk Analysis" – 5 years, 10 months ago
I agree with other about the ISO 14971 and Yiming Chen about the key terms. I would like to elaborate on the major phases of the risk management process aligning with ISO 14971 standard (Adding on to @jtl27‘s comment). Major… Read more»
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hzy2 replied to the topic Customer Needs, Business Requirements, Test Plan in the forum Introduction to Design Controls 6 years, 4 months ago
I’m so glad that we have capstone as a required class. I think it would be really nice if we got to do a capstone project for each year that we are in college. That way we would have the opportunity to expose ourselves to multiple projects that fall within the different tracks of BME. I feel like capstone gave me a good understanding of how…[Read more]
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thuytienlecao replied to the topic Discussion Topic: Risk Management, Risk Analysis in the forum Risk Analysis for Medical Devices 7 years, 4 months ago
I agree with other about the ISO 14971 and Yiming Chen about the key terms. I would like to elaborate on the major phases of the risk management process aligning with ISO 14971 standard (Adding on to @jtl27‘s comment). Major phases: risk analysis, risk evaluation, risk control, residual risk evaluation, risk/benefit analysis, evaluation of overall…[Read more]
