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Dhairya Parekh replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
I have had the opportunity to work on risk analysis at the company that I worked for in past. The risks were given numerical values based on three categories and the total risk was the product of these categories. It really depends on how the company sets up their risk analysis structure and “risk value.” It also comes back to the decision of the engineers and being confident in ensuring that you’re creating safe product and putting it on market.