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Design History File
A design history file is a compilation of documentation that describes the design history of a finished medical device. The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient. Prior to this legislation, U.S. Food and Drug Administration (FDA) auditors were limited to examining the production and quality control records of the device. Requirements The regulation requires medical device manufacturers of Class II and Class III devices to implement design controls. These design controls consist of a development and control plan used to manage the development of a new product, and a design history file where these activities are documented. These controls are specifically intended to manage a medical device company's new product development activities. Research and developm ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Document
A document is a written, drawn, presented, or memorialized representation of thought, often the manifestation of non-fictional, as well as fictional, content. The word originates from the Latin ''Documentum'', which denotes a "teaching" or "lesson": the verb ''doceō'' denotes "to teach". In the past, the word was usually used to denote written proof useful as evidence of a truth or fact. In the computer age, "document" usually denotes a primarily textual computer file, including its structure and format, e.g. fonts, colors, and images. Contemporarily, "document" is not defined by its transmission medium, e.g., paper, given the existence of electronic documents. "Documentation" is distinct because it has more denotations than "document". Documents are also distinguished from " realia", which are three-dimensional objects that would otherwise satisfy the definition of "document" because they memorialize or represent thought; documents are considered more as 2-dimensional rep ... [...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 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 UK votes to leave the EU in 2016; The Girardet bridge in Düsseldorf with its four pokéstops; Donald Trump is elected 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 States presidential election rect 300 200 600 400 2016 Summer Olympics rect 0 400 200 600 Pokémon Go rect 200 40 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Equipment
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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] |
Medical Equipment Management
Medical equipment management (sometimes referred to as clinical engineering, clinical engineering management, clinical technology management, healthcare technology management, biomedical maintenance, biomedical equipment management, and biomedical engineering) is a term for the professionals who manage operations, analyze and improve utilization and safety, and support servicing healthcare technology. These healthcare technology managers are, much like other healthcare professionals referred to by various specialty or organizational hierarchy names. Some of the titles of healthcare technology management professionals are biomed, biomedical equipment technician, biomedical engineering technician, biomedical engineer, BMET, biomedical equipment management, biomedical equipment services, imaging service engineer, imaging specialist, clinical engineer technician, clinical engineering equipment technician, field service engineer, field clinical engineer, clinical engineer, and medical ... [...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] |
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 * 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) 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 standards relating to rules for preparation of user guides, manuals, pro ... [...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 classification ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Title 21 Of The Code Of Federal Regulations
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). It is divided into three chapters: * Chapter I — Food and Drug Administration * Chapter II — Drug Enforcement Administration * Chapter III — Office of National Drug Control Policy Chapter I Most of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic Act. Notable sections: * 11 — electronic records and electronic signature related * 50 Protection of human subjects in clinical trials * 54 Financial disclosure by clinical investigators * 56 Institutional review boards that oversee clinical trials * 58 Good laboratory practices (GLP) for nonclinical studies The 100 series are regulations pertaining to food: * 101, especially 101.9 — Nutrition facts label related ** (c)(2)(ii) — Requirement to ... [...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 (F ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Research And Development
Research and development (R&D or R+D), known in Europe as research and technological development (RTD), is the set of innovative activities undertaken by corporations or governments in developing new services or products, and improving existing ones. Research and development constitutes the first stage of development of a potential new service or the production process. R&D activities differ from institution to institution, with two primary models of an R&D department either staffed by engineers and tasked with directly developing new products, or staffed with industrial scientists and tasked with applied research in scientific or technological fields, which may facilitate future product development. R&D differs from the vast majority of corporate activities in that it is not intended to yield immediate profit, and generally carries greater risk and an uncertain return on investment. However R&D is crucial for acquiring larger shares of the market through the marketisation ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
New Product Development
In business and engineering, new product development (NPD) covers the complete process of bringing a new product (business), product to market, renewing an existing product or introducing a product in a new market. A central aspect of NPD is product design, along with various business considerations. New product development is described broadly as the transformation of a market opportunity into a product available for sale. The products developed by an organisation provide the means for it to generate income. For many technology-intensive firms their approach is based on exploiting technological innovation in a rapidly changing market. The product can be tangible (something physical which one can touch) or intangible (like a service or user experience, experience), though sometimes services and other processes are distinguished from "products". NPD requires an understanding of customer needs and wants, the competitive environment, and the nature of the market. Cost, time, and qua ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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