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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.
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.
Design review; Design transfer ensuring that the device design is correctly translated into production specifications; Design changes; Design history file, a demonstration that the design was developed according to the approved design plan and 21 CFR 820.30.
With a broad definition, the contexts of design history include the social, the cultural, the economic, the political, the technical and the aesthetic. Design history has as its objects of study all designed objects including those of architecture, fashion, crafts, interiors, textiles, graphic design, industrial design and product design ...
A technical file is a set of documents that describes a product and can prove that the product was designed in accordance with the requirements of a quality management system. All products that have a CE mark must have a technical file which must contain the information that proves that the product conforms with the EU directives and ...
1.1 Basic heading and list format to organize your ... Toggle the table of contents. Wikipedia: User page design guide/Navigation ... History, politics, literature ...
A browser's cache stores temporary website files which allows the site to load faster in future sessions. This data will be recreated every time you visit the webpage, though at times it can become corrupted. Clearing the cache deletes these files and fixes problems like outdated pages, websites freezing, and pages not loading or being ...
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.