In October 2014, the US Food and Drug Administration (FDA) held a public workshop to gather feedbackfrom the manufacturing and medical device communities with regards to additive manufacturing. Theinsights from that workshop eventually led to the FDA guidance on Technical Considerations for AdditiveManufactured Medical Devices.There are many unique and vital questions that medical device engineers need to answer with regards toadditive manufacturing. While they are not difficult, it is new work compared to traditional applications.While the 30-page FDA guidance covers a number of important topics such as biocompatibility, softwaresecurity, and acceptance testing, there are three key areas of risk and where implementation strugglesexist that are worth delving deeper into.
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