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A design history file is a compilation of documentation that describes the design history of a finished medical device. The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical … See more The regulation requires medical device manufacturers of Class II and Class III devices to implement design controls. These design controls consist of a development and control plan used to manage the … See more • Device Master Record • Medical equipment management • Technical file See more Each manufacturer of either a class II or class III medical device (as well as a select group of class I devices) needs to establish and … See more The sub-clause 7.3.10 of ISO 13485:2016 requires a manufacturer of a medical device to maintain (and control) a design and development file for a medical device to document the … See more • CFR Title 21 Database See more WebThe plaintiffs and class are represented by Devin H. Fok of DHF Law PC and V. Andre Sherman of Girardi Keese. The case is Roger L Culberson II v. The Walt Disney Co ., case number BC526351, in the ... drew technologies mongoose pro
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