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4 causes of failure for medical devices

from By Emmet McMahan

Materials are one of the most common causes of failure in medical devices, especially for plastic. Records show that material failure is responsible for 30 to 40 percent of all FDA recalls on medical devices. The specific factors involved include the initial selection of material and over-reliance on the official specifications of those materials. The processes that materials undergo during manufacture and their operational conditions also contribute toward the probability of failure. more


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