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ashleyfitzsimmons replied to the topic Meat without Murder in the forum Introduction to Project Management 7 years, 5 months ago
In response to AnmolKaur, MDR is very important. If a medical device is resulting in deaths or injuries, it needs to be investigated and potentially taken off the market. After pre-clinical and clinical testing, even if a device is proven to be entirely safe, it still needs continuous monitoring. For example, a device may have only been tested for 6 months but after 2 years it may start to malfunction. MDR is a way to maintain consistent safety reporting across the board and to make sure that anything that shows the possibility to be unsafe is investigated and possibly taken off the market.