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Imaging Speaks Loudly to Medical Device Testing
By Gil Zweig, President, Glenbrook Technologies
Over the years, FDA has issued a number of documents that provide guidance for industry and FDA staff, with sections that address the application of x-ray inspection procedures in the testing of medical devices. The particular focus of these documents has been on cardiovascular devices, which include intravascular stents and associated delivery systems.
Document number 1545, issued in 2010, addresses non-clinical engineering tests and …….