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A Design History File (DHF) is a compilation of documentation that describes the design history of a finished medical device. The Design History File encompasses the objective evidence that the design has been developed in accordance with the Design and Development Plan, in compliance with regulatory requirements and design control requirements.
DHF for Medical Devices is a regulatory trending activity which ensures Manufacturers are up to date and aligned for stringent compliance's of Design Controls. This paper includes the details of all Design History File modules and important components or sections under each module related to 21.CFR820 and ISO 13485.