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ISO 13485
ISO 13485 ''Medical devices -- Quality management systems -- Requirements for regulatory purposes'' is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996). The current ISO 13485 edition was published on 1 March 2016. Background Though it is tailored to the industry's quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automotive Task ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
International Organization For Standardization
The International Organization for Standardization (ISO ; ; ) is an independent, non-governmental, 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 () it has published over 25,000 international standards covering almost all aspects of technology and manufacturing. It has over 800 technical committees (TCs) and subcommittees (SCs) to take care of standards development. The organization develops and publishes international standards in technical and nontechnical fields, including everything from manufactured products and technology to food safety, transport, IT, agriculture, and healthcare. More specialized topics like electrical and electronic engineering are instead handled by the International Electrotechnical Commission.Editors of Encyclopedia Britannica. 3 June 2021.Inte ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Corrective And Preventive Action
Corrective and preventive action (CAPA or simply corrective action) consists of improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. It is usually a set of actions, laws or regulations required by an organization to take in manufacturing, documentation, procedures, or systems to rectify and eliminate recurring non-conformance. Non-conformance is identified after systematic evaluation and analysis of the root cause of the non-conformance. Non-conformance may be a market complaint or customer complaint or failure of machinery or a quality management system, or misinterpretation of written instructions to carry out work. The corrective and preventive action is designed by a team that includes quality assurance personnel and personnel involved in the actual observation point of non-conformance. It must be systematically implemented and observed for its ability to eliminate further recurrence of such non-conformation. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulation Of Medical Devices
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 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 was not until the Federal Food, Drug, and Cosmetic Act (FD&C Act) in ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
ISO Standards
The International Organization for Standardization (ISO ; ; ) is an independent, non-governmental, 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 () it has published over 25,000 international standards covering almost all aspects of technology and manufacturing. It has over 800 technical committees (TCs) and subcommittees (SCs) to take care of standards development. The organization develops and publishes international standards in technical and nontechnical fields, including everything from manufactured products and technology to food safety, transport, IT, agriculture, and healthcare. More specialized topics like electrical and electronic engineering are instead handled by the International Electrotechnical Commission.Editors of Encyclopedia Britannica. 3 June 2021.Interna ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
List Of International Organization For Standardization Standards
This is a list of publishedThis list generally excludes draft versions. standards and other deliverables of the International Organization for Standardization (ISO).ISO deliverables include "specifications" (ISO/PAS, ISO/TS), "reports" (ISO/TR), etc, which are not referred to by ISO as "standards". For a complete and up-to-date list of all the ISO standards, see the ISO catalogue. The standards are protected by and most of them must be purchased. However, about 300 of the standards produced by ISO and IEC's Joint Technical Committee 1 ( [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Manufacturing Practice
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality manageme ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
ISO 14971
ISO 14971 ''Medical devices — Application of risk management to medical devices'' is a voluntary consensus standard, published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices. The current ISO 14971 edition was published in December 2019. Background The ISO Technical Committee responsible for the maintenance of this standard is ISO/ TC 210 working with IEC/SC62A through Joint Working Group one (JWG1). This standard is the culmination of the work starting in ISO/IEC Guide 51, and ISO/IEC Guide 63. The third edition of ISO 14971 was published in December 2019 and supersedes the second edition of ISO 14971. Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and review, and also specifies a procedure for review and monitoring during production and post-production. ISO 14971:2012 w ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Committee For Standardization
The European Committee for Standardization (CEN, ) is a public standards organization whose mission is to foster the economy of the European Single Market and the wider European continent in global trading, the welfare of European citizens and the environment by providing an efficient infrastructure to interested parties for the development, maintenance and distribution of coherent sets of standards and specifications. The CEN was founded in 1961. Its thirty-four national members work together to develop European Standards (ENs) in various sectors to build a European internal market for goods and services and to position Europe in the global economy. CEN is officially recognized as a European standards body by the European Union, European Free Trade Association and the United Kingdom; the other official European standards bodies are the European Committee for Electrotechnical Standardization ( CENELEC) and the European Telecommunications Standards Institute (ETSI). More tha ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Federal Commission For The Protection Against Sanitary Risk
The Federal Commission for Protection against Health Risks (in Spanish, Comisión Federal para la Protección contra Riesgos Sanitarios, Cofepris) is a regulatory body of the Mexican government. It is a decentralized organ of (and supervised by) the Mexican Secretariat of Health, and is responsible for regulating a variety of health related topics in Mexico, including food safety, pharmaceutical drugs, medical devices, organ transplants, and environmental protection. COFEPRIS headquarters in Mexico City References See also *Food and Drug Administration (Similar organization in the United States) * Health Canada Health Canada (HC; )Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the Structure of the Canadian federal government#Departments, with subsidiary units, department of the Gove ... (Similar organization in Canada) Medical and health organizations based in Mexico National agencies for drug regula ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Norma Oficial Mexicana
The Norma Oficial Mexicana (Official Mexican Standard), abbreviated NOM, is the name of each of a series of official, compulsory standards and regulations for diverse activities in Mexico. They are more commonly referred to as ''NOMs'' or ''normas''. The standards are prepared by the ''Dirección General de Normas (DGN)'' (Directorate-General of Standards), which is the body representing Mexico in the International Organization for Standardization (ISO). Examples Tequila In the case of tequila, Mexico's Tequila Regulatory Council (CRT) regulates production NOMs. The NOM identifier means the tequila meets government standards - but this is not any guarantee of tequila's quality. However, without the NOM stamp of legitimacy, it is not guaranteed that the bottle contains tequila. All 100% agave tequilas must have a NOM identifier on the bottle. The important laws since 1990 were NOM-006-SCFI-1993 and the later update NOM-006-SCFI-1994 revised in late 2005 NOM-006-SCFI-2005 and the ... [...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 * Internationalism (politics) * Political international, a ... [...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 , , |
