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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 devices that can cause or contribute to the death, serious illness, or injury of a patient.
APA style (also known as APA format) is a writing style and format for academic documents such as scholarly journal articles and books. It is commonly used for citing sources within the field of behavioral and social sciences , including sociology, education, nursing, criminal justice, anthropology, and psychology.
A style guide, or style manual, is a set of standards for the writing and design of documents, either for general use or for a specific publication, organization or field. The implementation of a style guide provides uniformity in style and formatting within a document and across multiple documents.
Device History Record (DHR) Design History File (DHF) The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
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Historically, most classes of technical documentation lacked universal conformity for format, content and structure. Standards are being developed to redress this through bodies such as the International Organization for Standardization(ISO), which has published standards relating to rules for preparation of user guides, manuals, product specifications, etc. for technical product documentation.
This page contains examples of various types of inline citations. Variations on all of the examples included here exist throughout Wikipedia. As of July 2009, Wikipedia's guideline on citation styles includes the following guidance: All citation techniques require detailed full citations to be provided for each source used.
This page lists ways to create several kinds of compact tables of contents (TOC). Please note that a normal compact TOC will not work when put on Category pages; this page contains a separate section instructing you how to put a compact TOC on Category pages.