17-570: 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 . Prior to this legislation, U.S. Food and Drug Administration (FDA) auditors were limited to examining
34-422: A graphic designer . Typography concerns the design of letter and symbol forms and their physical arrangement in the document (see typesetting ). Information design concerns the effective communication of information , especially in industrial documents and public signs . Simple textual documents may not require visual design and may be drafted only by an author , clerk , or transcriber . Forms may require
51-608: A design and development plan, or test reports; and is thus comparable to the DHF of the FDA regulations. Similarly, Annex II §3.1 of the EU medical device regulation asks for information to allow the design stages applied to the device to be understood to be part of the Technical documentation . Document A document is a written , drawn , presented, or memorialized representation of thought, often
68-402: A document is copied , the source is denominated the " original ". Documents are used in numerous fields, e.g.: Such standard documents can be drafted based on a template . The page layout of a document is how information is graphically arranged in the space of the document, e.g., on a page. If the appearance of the document is of concern, the page layout is generally the responsibility of
85-514: A mail message or a technical report , exists physically in digital technology as a string of bits, as does everything else in a digital environment. As an object of study, it has been made into a document. It has become physical evidence by those who study it. "Document" is defined in library and information science and documentation science as a fundamental, abstract idea: the word denotes everything that may be represented or memorialized to serve as evidence . The classic example provided by Briet
102-484: A medical device company's new product development activities. Research and development processes aimed at developing new underlying technologies are not subject to these regulations. The requirements for a DHF are documented in FDA Regulation CFR 21 820. 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 document procedures on
119-579: A sharp tool, e.g., the Tablets of Stone described in the Bible ; stamped or incised in clay and then baked to make clay tablets , e.g., in the Sumerian and other Mesopotamian civilizations. The papyrus or parchment was often rolled into a scroll or cut into sheets and bound into a codex (book). Contemporary electronic means of memorializing and displaying documents include: Digital documents usually require
136-414: A specific file format to be presentable in a specific medium. Documents in all forms frequently serve as material evidence in criminal and civil proceedings. The forensic analysis of such a document is within the scope of questioned document examination . To catalog and manage the large number of documents that may be produced during litigation , Bates numbering is often applied to all documents in
153-534: A visual design for their initial fields, but not to complete the forms. Traditionally, the medium of a document was paper and the information was applied to it in ink , either by handwriting (to make a manuscript ) or by a mechanical process (e.g., a printing press or laser printer ). Today, some short documents also may consist of sheets of paper stapled together. Historically, documents were inscribed with ink on papyrus (starting in ancient Egypt ) or parchment ; scratched as runes or carved on stone using
170-400: Is an antelope : "An antelope running wild on the plains of Africa should not be considered a document[;] she rules. But if it were to be captured, taken to a zoo and made an object of study, it has been made into a document. It has become physical evidence being used by those who study it. Indeed, scholarly articles written about the antelope are secondary documents, since the antelope itself is
187-541: Is not defined by its transmission medium , e.g., paper, given the existence of electronic documents . "Documentation" is distinct because it has more denotations than "document". Documents are also distinguished from " realia ", which are three-dimensional objects that would otherwise satisfy the definition of "document" because they memorialize or represent thought; documents are considered more as two-dimensional representations. While documents can have large varieties of customization, all documents can be shared freely and have
SECTION 10
#1733093458195204-415: The design and design requirements. These design controls include: 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 design history of a medical device. This file shall also contain records for changes in design and development (per device type or family). It might contain e.g.
221-608: The manifestation of non-fictional , as well as fictional , content. The word originates from the Latin Documentum , which denotes a "teaching" or "lesson": the verb doceō denotes "to teach". In the past, the word was usually used to denote written proof useful as evidence of a truth or fact. In the Computer Age , "document" usually denotes a primarily textual computer file , including its structure and format, e.g. fonts, colors, and images . Contemporarily, "document"
238-406: The other documentalists increasingly emphasized whatever functioned as a document rather than traditional physical forms of documents. The shift to digital technology would seem to make this distinction even more important. David M. Levy has said that an emphasis on the technology of digital documents has impeded our understanding of digital documents as documents. A conventional document, such as
255-429: The primary document." This opinion has been interpreted as an early expression of actor–network theory . A document can be structured, like tabular documents, lists , forms , or scientific charts, semi-structured like a book or a newspaper article , or unstructured like a handwritten note. Documents are sometimes classified as secret , private , or public. They may also be described as drafts or proofs . When
272-413: The production and quality control records of the device. 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 development of a new product, and a design history file where these activities are documented. These controls are specifically intended to manage
289-505: The right to do so, creativity can be represented by documents, also. History, events, examples, opinions, stories etc. all can be expressed in documents. The concept of "document" has been defined by Suzanne Briet as "any concrete or symbolic indication, preserved or recorded, for reconstructing or for proving a phenomenon, whether physical or mental." An often-cited article concludes that "the evolving notion of document " among Jonathan Priest, Paul Otlet , Briet, Walter Schürmeyer , and
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