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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 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 engineering, electrical and electronic engineering, which is handled by the International Electrotechnical Commission, 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 coun ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
ISO 14971
ISO 14971 ''Medical devices — Application of risk management to medical devices'' is a voluntary standard for the application of risk management to medical devices. "Voluntary standards do not replace national laws, with which standards' users are understood to comply and which take precedence" over voluntary standards such as ISO 13485 and ISO 14971. 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 was harmonized with respect ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulation Of Medical Devices
Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For example: * in biology, gene regulation and metabolic regulation allow living organisms to adapt to their environment and maintain homeostasis; * in government, typically regulation means stipulations of the delegated legislation which is drafted by subject-matter experts to enforce primary legislation; * in business, industry self-regulation occurs through self-regulatory organizations and trade associations which allow industries to set and enforce rules with less government involvement; and, * in psychology, self-regulation theory is the study of how individuals regulate their thoughts and behaviors to reach goals. Social Regulation in the social, political, psychological, and economic domains can take many forms: legal restrictio ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
ISO Standards
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, Fre ... [...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. International Organization for Standardization (ISO) standards and other deliverables.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 copyright 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 manag ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Committee For Standardization
The European Committee for Standardization (CEN, french: Comité Européen de Normalisation) 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 Telecommunic ... [...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; french: Santé Canada, SC)Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the department of the Government of Canada responsible for national health poli ... (Similar organization in Canada) Medical and health organizations based in Mexico National agencies for drug regulat ... [...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 th ... [...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] |
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] |
CE Mark
On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certification mark. The CE marking is required for goods sold in the European Economic Area (EEA), but is also found on products sold elsewhere that have been manufactured to EEA standards. The mark indicates that the product may be traded freely in any part of the European Economic Area, regardless of its country of origin. It consists of the CE logo and, if applicable, the four digit identification number of the notified body involved in the conformity assessment procedure. "CE" is the abbreviation of (French for "European conformity"). Meaning The mark on a product indicates that the manufacturer or importer of that product affirms its compliance with the relevant EU legislation and the product may be sold anywhere in the European Economi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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