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Technical File
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 regulations for CE-marked products. EU enforcement authorities may demand a copy of the technical file for many years after the last product was made. Customers do not usually have access to the technical file. Content A technical file is usually based on a document archive system that ensures longevity of documents and can either be on paper or in electronic files. It can include drawings, specifications, reports, review records, meeting minutes, labels, instructions for use, software source code, production process flow charts, etc. One document may be named "technical file" and list all other documents that are considered part of the technical fil ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
CE Marking
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 Economic Ar ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Competent Authority
A competent authority is any person or organization that has the legally delegated or invested authority, capacity, or power to perform a designated function. Similarly, once an authority is delegated to perform a certain act, only the competent authority is entitled to take accounts therefrom and no one else. Borrowing authority when the services of a certain class of individuals are entrusted to one of the authority other than the appointing authority, the former will be the borrowing authority. Borrowing Authority will be authorised to look into the performance of individuals with respect to the task so assigned to them. Borrowing authority, service conduct when it appears to the borrowing authority the conduct of the individuals not in accordance with the standard prescribed, it will move in writing to the appointing authority the conduct so observed with the evidence so brought on record for proceedings therein. Appointing authority, however, is not competent to proceed a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
2016
File:2016 Events Collage.png, From top left, clockwise: Bombed-out buildings in Ankara following the 2016 Turkish coup d'état attempt; the Impeachment of Dilma Rousseff, impeachment trial of Brazilian President Dilma Rousseff; Damaged houses during the 2016 Nagorno-Karabakh conflict; A scene from the opening ceremony of the 2016 Summer Olympics in Rio de Janeiro, Brazil; Queues outside a bank to exchange demonetized banknotes during the 2016 Indian banknote demonetisation; the United Kingdom, UK votes to Brexit, leave the European Union, EU in 2016; The Girardet bridge in Düsseldorf with its four Pokémon Go, pokéstops; Donald Trump is elected 2016 United States presidential election, as U.S. President in 2016 during a period of intensifying political polarization in the United States, 300x300px, thumb rect 0 0 200 200 2016 Turkish coup d'état attempt rect 200 0 400 200 Impeachment of Dilma Rousseff rect 400 0 600 200 2016 Nagorno-Karabakh conflict rect 0 200 300 400 2016 United ... [...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 (FD&C ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
EU Medical Device Regulation
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC (MDD), which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021. The regulation was published on 5 April 2017 and came into force on 25 May 2017. Originally approved medical devices will have a transition time of three years (until 26 May 2021) to meet new requirements. Changes Changes compared to the Medical Device Directive include changes in device classification and device scope, stricter oversight of manufacturers by Notified Bodies, introduction of the "Person Responsible for Regulatory Compliance" (PRRC) and of the economic operator concept, the requirement of Unique Device Identification marking for devices, EUDAMED registration (see below), UDI requirements, and increased post-market surveillance activities. Scope and classificati ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulation (EU) 2017/746
Regulation (EU) 2017/746 (IVDR) is a regulation 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. Fo ... of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices. Changes compared to the IVDD include changes in device classification, stricter oversight of manufacturers by Notified Bodies, introduction of the "Person Responsible for Regulatory Compliance" (PRRC), the requirement of UDI marking for devices, common specifications, Eudamed registration, and increased post-market surveillance activities. Classification The regulation introduces the classifi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Technical Documentation
Technical documentation is a generic term for the classes of information created to describe (in technical language) the use, functionality or architecture of a product, system or service. Classes of technical documentation Classes of technical documentation may include: * patents * Specification (technical standard), specifications of item or of components/materials * data sheets of item or of components/materials * test methods * manufacturing standards * system requirements * system architecture * system design documents and data including those necessary for the system development, testing, manufacturing, operation and maintenance Standardizing technical documentation Historically, most classes of technical documentation lacked universal conformity Standards organization, (standards) 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 International st ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Device Master Record
A Device Master Record (DMR) is a compilation of all the instructions, drawings and other records that must be used to produce a product. The term is used in Quality Management Systems that cover product design and production. Contents The physical appearance of the DMR can be a binder with documents, a document that can refer to other documents, or the same concepts in a computer as documents in a database. Labels, Instructions for Use, drawings, Certificates of Conformity, and other documents might form part of a DMR. The following contents are listed in the relevant chapter of the CFR as part of the Device Master Record: (a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications; (b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications; (c) Quality assurance procedures and specifica ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality Management
Quality management ensures that an organization, product or service consistently functions well. It has four main components: quality planning, quality assurance, quality control and quality improvement. Quality management is focused not only on product and service quality, but also on the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. Quality control is also part of quality management. What a customer wants and is willing to pay for it, determines quality. It is a written or unwritten commitment to a known or unknown consumer in the market. Quality can be defined as how well the product performs its intended function. Evolution Quality management is a recent phenomenon but important for an organization. Civilizations that supported the arts and crafts allowed clients to choose goods meeting higher quality standards than normal goods. In societies where arts and cr ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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