The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). 1 With a nod to the late Eddie ...
FDA uses a range of biocompatibility test data to evaluate medical devices before clearing or approving them for marketing. The growing use of FDA-recognized consensus standards facilitates this ...
As data-driven innovation profoundly changes every industry, the healthcare sector is also affected. Digital twins – virtual copies of physical devices – are essentially changing the ...
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