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jjp93 replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices 6 years, 5 months ago
I believe this article has a many valid points. Risk management and design control should be used together to make sure everything runs smoothly for the product that is being designed. If they are used separately, many simple mistakes can occur that can cause problems in the future. Some mistakes that occur are not doing documentation when it’s necessary and holding it off for later. The article states to do it right away and not to do it later because you won’t have time later which is absolutely true. Many people think paperwork wastes a lot of time but it’s necessary to do it because when an issue occurs, you can use this paperwork to backtrack and see where the problem happened and solve it. Risk management should also be used during every aspect of the medical device development. If different departments are not looking at risk management for their portion of the design then more risks can arise in the future. Devices are used to help people but it has to be risk proof for people to use it otherwise it’ll be harder to sell or use for patients. I also believe something that is very important for risk management is reviewing everything that is done to make sure nothing was missed in the first place. Taking a second glance from multiple people can help to find mistakes and help the device become safer. Also simple mistakes should never be overlooked because these can cause bigger issues in the future as well.