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Design history file information


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 devices that can cause or contribute to the death, serious illness, or injury of a patient.[1][page needed] Prior to this legislation, U.S. Food and Drug Administration (FDA) auditors were limited to examining the production and quality control records of the device.[citation needed]

  1. ^ Harnack, Gordon (1999). Mastering and Managing the FDA Maze: Medical Device Overview. American Society for Quality. ISBN 9780873894555. Retrieved January 13, 2017.[page needed]

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Design history file

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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...

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File transfer

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communications protocol. In the history of computing, numerous file transfer protocols have been designed for different contexts. A file transfer protocol is a...

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Design of the FAT file system

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Device Master Record

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the design process, that is covered in the Design Dossier or Design History File (DHF). After a product design department has updated their design documents...

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List of file formats

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a list of file formats used by computers, organized by type. Filename extension is usually noted in parentheses if they differ from the file format's name...

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Touchstone file

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A Touchstone file was originally a proprietary file format for the eponymous frequency-domain linear circuit simulator from EEsof, launched in 1984 and...

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Design controls

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production specifications Design changes Design history file, a demonstration that the design was developed according to the approved design plan and 21 CFR 820...

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AutoCAD version history

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editor program. The file format version code is dependent on the AutoCAD version. The following table summarizes the version history of the AutoCAD software...

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This is a timeline of events in the history of networked file sharing. 1976 – Xmodem a point-to-point binary transfer protocol by Ward Christensen. February...

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ExFAT

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elements of its design. exFAT can be used where NTFS is not a feasible solution (due to data-structure overhead), but where a greater file-size limit than...

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Comparison of file transfer protocols

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protocols that are designed for file transfer over a telecommunications network. Protocols for shared file systems—such as 9P and the Network File System—are...

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File manager

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Electronic design automation

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Electronic design automation (EDA), also referred to as electronic computer-aided design (ECAD), is a category of software tools for designing electronic...

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SSH File Transfer Protocol

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was designed by the Internet Engineering Task Force (IETF) as an extension of the Secure Shell protocol (SSH) version 2.0 to provide secure file transfer...

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Object file

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when the program is loaded. The design and/or choice of an object file format is a key part of overall system design. It affects the performance of the...

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INI file

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An INI file is a configuration file for computer software that consists of a text-based content with a structure and syntax comprising key–value pairs...

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Version control

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controlling computer files and versions of files. Primarily files are source code text files, but generally can be any type of file. Version control is...

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products that are designed for online file storage may not have features or characteristics that others designed for sharing files have. Cloud storage...

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CorelDRAW

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Graphic design

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professionals. Graphic design has been practiced in various forms throughout history; in fact, good examples of graphic design date back to manuscripts...

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Adobe Illustrator

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AutoCAD file formats — Implemented by Drawings SDK (previously Teigha Drawings) by Open Design Alliance. AutoCAD Drawing (.dwg) AutoCAD Interchange File (.dxf)...

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Clustered file system

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protocol is designed. The difference between a distributed file system and a distributed data store is that a distributed file system allows files to be accessed...

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ES File Explorer

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ES File Explorer is a file manager/explorer designed by ES Global, a subsidiary of DO Global, for Android devices. It includes features like cloud storage...

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Gerber format

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Goering, Cadence Design Systems blog, 2011-10-02 Official website Gerber Documents - Ucamco Gerber File Viewer - Ucamco Free Gerber File Viewer Online -...

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