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gaberuiz13 replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices 7 years, 4 months ago
I feel as though all the mistakes you mentioned highlights the fault in companies when it comes to understanding how to handle risk management. I agree that risk management and design control are separate things and that risk management should be treated like a checkbox activity that can be used to improve the design as its being designed as opposed to leaving the task for later in the development process. One thing I don’t totally agree with that is considered a mistake is the use of the Failure-Mode and Effect Analysis (FMEA). I fell as though the FMEA is good assessment of potential risks for a product and should be considered in order to easily visualize all the risks and their severity. FMEA is a good predictor of whether or not a project is worth pursuing or not; however, I think the mistake the article mentions stems from this idea that risk management is being handled later the development process. If the FMEA is utilized early-on, it can save the company a lot of trouble. With that being said, I also agree with the notion that the risk management document should be a living document that is aggressively updated in order to cover things that may appear suddenly somewhere in the development process.