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GMDN
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans. The main purpose of the GMDN is to provide health authorities / regulators, health care providers, conformity assessment bodies and others with a single generic naming system. Medical device experts from around the world (manufacturers, healthcare authorities and regulators) compiled the GMDN, based on the international standard ISO 15225. Governance The GMDN meets the need to identify medical devices at the global level, as identified in the Global Harmonization Task Force (GHTF) that have since disbanded (2012) and replaced by the IMDRF GMDN is managed by the GMDN Agency, a non-profit organization and Registered Charity, which reports to its Board of Trustees, th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Classification
A medical classification is used to transform descriptions of medical diagnoses or procedures into standardized statistical code in a process known as clinical coding. Diagnosis classifications list diagnosis codes, which are used to track diseases and other health conditions, inclusive of chronic diseases such as diabetes mellitus and heart disease, and infectious diseases such as norovirus, the flu, and athlete's foot. Procedure classifications list procedure code, which are used to capture interventional data. These diagnosis and procedure codes are used by health care providers, government health programs, private health insurance companies, workers' compensation carriers, software developers, and others for a variety of applications in medicine, public health and medical informatics, including: * statistical analysis of diseases and therapeutic actions * reimbursement (e.g., to process claims in medical billing based on diagnosis-related groups) * knowledge-based and deci ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Nomenclature
Nomenclature (, ) is a system of names or terms, or the rules for forming these terms in a particular field of arts or sciences. The principles of naming vary from the relatively informal conventions of everyday speech to the internationally agreed principles, rules and recommendations that govern the formation and use of the specialist terms used in scientific and any other disciplines. Naming "things" is a part of general human communication using words and language: it is an aspect of everyday taxonomy as people distinguish the objects of their experience, together with their similarities and differences, which observers identify, name and classify. The use of names, as the many different kinds of nouns embedded in different languages, connects nomenclature to theoretical linguistics, while the way humans mentally structure the world in relation to word meanings and experience relates to the philosophy of language. Onomastics, the study of proper names and their origins, in ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it wasn't until the Federal Food, Drug, and Cosmetic Act ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Global Harmonization Task Force
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry”GHTF General Information whose goal was the standardization of medical device regulation across the world. The representatives from its five founding members (the , the , , [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Non-profit Organization
A nonprofit organization (NPO) or non-profit organisation, also known as a non-business entity, not-for-profit organization, or nonprofit institution, is a legal entity organized and operated for a collective, public or social benefit, in contrast with an entity that operates as a business aiming to generate a profit for its owners. A nonprofit is subject to the non-distribution constraint: any revenues that exceed expenses must be committed to the organization's purpose, not taken by private parties. An array of organizations are nonprofit, including some political organizations, schools, business associations, churches, social clubs, and consumer cooperatives. Nonprofit entities may seek approval from governments to be tax-exempt, and some may also qualify to receive tax-deductible contributions, but an entity may incorporate as a nonprofit entity without securing tax-exempt status. Key aspects of nonprofits are accountability, trustworthiness, honesty, and openness to ev ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Charitable Organization
A charitable organization or charity is an organization whose primary objectives are philanthropy and social well-being (e.g. educational, religious or other activities serving the public interest or common good). The legal definition of a charitable organization (and of charity) varies between countries and in some instances regions of the country. The regulation, the tax treatment, and the way in which charity law affects charitable organizations also vary. Charitable organizations may not use any of their funds to profit individual persons or entities. (However, some charitable organizations have come under scrutiny for spending a disproportionate amount of their income to pay the salaries of their leadership). Financial figures (e.g. tax refund, revenue from fundraising, revenue from sale of goods and services or revenue from investment) are indicators to assess the financial sustainability of a charity, especially to charity evaluators. This information can impact a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Copyright
A copyright is a type of intellectual property that gives its owner the exclusive right to copy, distribute, adapt, display, and perform a creative work, usually for a limited time. The creative work may be in a literary, artistic, educational, or musical form. Copyright is intended to protect the original expression of an idea in the form of a creative work, but not the idea itself. A copyright is subject to Limitations and exceptions to copylimitations based on public interest considerations, such as the fair use doctrine in the United States. Some jurisdictions require "fixing" copyrighted works in a tangible form. It is often shared among multiple authors, each of whom holds a set of rights to use or license the work, and who are commonly referred to as rights holders. These rights frequently include reproduction, control over derivative works, distribution, Performing rights, public performance, and moral rights such as attribution. Copyrights can be granted by public l ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Trademark
A trademark (also written trade mark or trade-mark) is a type of intellectual property consisting of a recognizable sign, design, or expression that identifies products or services from a particular source and distinguishes them from others. The trademark owner can be an individual, business organization, or any legal entity. A trademark may be located on a package, a label, a voucher, or on the product itself. Trademarks used to identify services are sometimes called service marks. The first legislative act concerning trademarks was passed in 1266 under the reign of Henry III of England, requiring all bakers to use a distinctive mark for the bread they sold. The first modern trademark laws emerged in the late 19th century. In France, the first comprehensive trademark system in the world was passed into law in 1857. The Trade Marks Act 1938 of the United Kingdom changed the system, permitting registration based on "intent-to-use", creating an examination based pro ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
US FDA
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying from ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
International Organization For Standardization
The International Organization for Standardization (ISO ) is an international standard development organization composed of representatives from the national standards organizations of member countries. Membership requirements are given in Article 3 of the ISO Statutes. ISO was founded on 23 February 1947, and (as of November 2022) it has published over 24,500 international standards covering almost all aspects of technology and manufacturing. It has 809 Technical committees and sub committees to take care of standards development. The organization develops and publishes standardization in all technical and nontechnical fields other than electrical and electronic engineering, which is handled by the IEC.Editors of Encyclopedia Britannica. 3 June 2021.International Organization for Standardization" ''Encyclopedia Britannica''. Retrieved 2022-04-26. It is headquartered in Geneva, Switzerland, and works in 167 countries . The three official languages of the ISO are English, F ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
International Medical Device Regulators Forum
International is an adjective (also used as a noun) meaning "between nations". International may also refer to: Music Albums * ''International'' (Kevin Michael album), 2011 * ''International'' (New Order album), 2002 * ''International'' (The Three Degrees album), 1975 *''International'', 2018 album by L'Algérino Songs * The Internationale, the left-wing anthem * "International" (Chase & Status song), 2014 * "International", by Adventures in Stereo from ''Monomania'', 2000 * "International", by Brass Construction from ''Renegades'', 1984 * "International", by Thomas Leer from ''The Scale of Ten'', 1985 * "International", by Kevin Michael from ''International'' (Kevin Michael album), 2011 * "International", by McGuinness Flint from ''McGuinness Flint'', 1970 * "International", by Orchestral Manoeuvres in the Dark from '' Dazzle Ships'', 1983 * "International (Serious)", by Estelle from '' All of Me'', 2012 Politics * Political international, any transnational organization ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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