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Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
Medical writing for the pharmaceutical industry can be classified as either regulatory medical writing or educational medical writing. [citation needed] Regulatory medical writing means creating the documentation that regulatory agencies require in the approval process for drugs, devices and biologics. Regulatory documents can be huge and are ...
This is an accepted version of this page This is the latest accepted revision, reviewed on 9 December 2024. Economic sector focused on health An insurance form with pills The healthcare industry (also called the medical industry or health economy) is an aggregation and integration of sectors within the economic system that provides goods and services to treat patients with curative, preventive ...
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.
The 2002 Medical Device User Fee and Modernization Act (MDUFA) first granted FDA the authority to collect user fees from industry to help the FDA improve efficiency, quality, and predictability of medical device submission reviews; the medical device user fee program has been reauthorized several times with the most recent in 2022.
A journal entry is the act of keeping or making records of any transactions either economic or non-economic. Transactions are listed in an accounting journal that shows a company's debit and credit balances. The journal entry can consist of several recordings, each of which is either a debit or a credit. The total of the debits must equal the ...
Medical education applies theories of pedagogy specifically in the context of medical education. Medical education has been a leader in the field of evidence-based education, through the development of evidence syntheses such as the Best Evidence Medical Education collection, formed in 1999, which aimed to "move from opinion-based education to evidence-based education". [2]