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bnb6 replied to the topic Risk Management in the forum Project Management Process and Medical Device Development 7 years, 1 month ago
One medical device of my particular interest would be total knee replacements. One specific risk of knee replacements is loosening due to wear and tear over the years. Worst case scenario the implant would have to be removed, and a secondary replacement system will have to be implanted after resecting even more bone. Companies manage this risk by educating the surgeons on the proper surgical technique using booklets or even certification classes. The statistics on post implant success is recorded to determine if the risk prevention process has been improved.