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  • jk299 replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices 8 years, 4 months ago

    I agree with the last one in the sense that companies should, if they don’t already do, perform risk analysis and risk management on the product all throughout the product lifecycle as a way to ensure the customer and the public that the product is safe, effective and practical. This would increase sales and increase confidence in the product. Risk management is one area where no corners should be cut and that the company is should routinely do to ensure this. And less assumptions should be taken on the companies end and more so on if this is the claim prove it and prove everything, no assumptions for the risk analysis should be made.