Viewpoint: Why Won’t Some Manufacturers Release Service Manuals?
One of the questions the U.S. FDA asked in its 2016 Request for Comments was: “What information do third-party entities need in order to perform…the safe and effective operation of medical devices?” Not surprisingly, both manufacturers and third-parties organizations cited service manuals—although some manufacturers seem reluctant to release such information. Here, Binseng Wang spells out the reasons some OEMs are giving to defend their actions.
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