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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
The presence of the logo on Product (business), commercial products indicates that the Manufacturing, manufacturer or importer affirms the goods' conformity with European Environment, health and safety, health, safety, and environmental protection Technical standard, 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); goods sold elsewhere may also carry the mark. 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. Meaning The mark on a product indicates that the manufacturer or importer of that product affirms its compliance with the relevant European Union law, EU legislation and the product may be sold anywhere in the European Economic Area (EEA) ... [...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 aga ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
2016
2016 was designated as: * International Year of Pulses by the sixty-eighth session of the United Nations General Assembly. * International Year of Global Understanding (IYGU) by the International Council for Science (ICSU), the International Social Science Council (ISSC), and the International Council for Philosophy and Human Sciences (CIPSH). __TOC__ Events January * January 3 – Following 2016 attack on the Saudi diplomatic missions in Iran, the fallout caused by the Nimr al-Nimr#Execution and reaction against, execution of Nimr al-Nimr, Saudi Arabia and several other countries end their Iran–Saudi Arabia relations, diplomatic relations with Iran. * January 8 – Joaquín "El Chapo" Guzmán, Joaquín Guzmán, widely regarded as the world's most powerful drug trafficker, is recaptured following his escape from a maximum-security prison in Mexico. * January 10 – English singer, songwriter, musician, and actor David Bowie dies in his New York City apartm ... [...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 in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of Archaeology, 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 ( ... [...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 placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD). The regulation was published on 5 April 2017 and came into force on 25 May 2017. 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 postmarketing surveillance activities. Scope and classification Compared to the MDD, the scope of the MDR has been expanded to cover not only the active implantable medical devices previously covered b ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulation (EU) 2017/746
Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic 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 assura ... (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, in §47, th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Technical Documentation
Technical may refer to: * Technical (vehicle), an improvised fighting vehicle * Technical area, an area which a manager, other coaching personnel, and substitutes are allowed to occupy during a football match * Technical advisor, a person who advises the director on the convincing portrayal of a subject in a film production * Technical analysis, a discipline for forecasting the future direction of prices through the study of past market data * Technical drawing, showing how something is constructed or functions (also known as drafting) ** Technical file, a set of technical drawings * Technical death metal, a subgenre of death metal that focuses on complex rhythms, riffs, and song structures * Technical foul, an infraction of the rules in basketball usually concerning unsportsmanlike non-contact behavior * Technical geography, one of the main branches of geography * Technical rehearsal for a performance, often simply referred to as a technical * Technical support, a rang ... [...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 specificat ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality Management
Total quality management, Total Quality management (TQM), ensures that an organization, product, or service consistently performs as intended, as opposed to Quality Management, which focuses on work process and procedure standards. It has four main components: quality planning, quality assurance, quality control, and quality improvement. Customers recognize that quality is an important attribute when choosing and purchasing products and services. Suppliers can recognize that quality is an important differentiator of their offerings, and endeavor to compete on the quality of their products and the service they offer. Thus, quality management is focused both on product and service quality. Advancement In earlier periods, arts and crafts were led by Master craftsman, master craftspeople or artists who supervised studios, trained apprentices, and oversaw the product development process. With the advent of the Industrial Revolution, steam engines, and mass production, the role of crafts ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
