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DHF
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 development ... [...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] |
Document
A document is a writing, written, drawing, drawn, presented, or memorialized representation of thought, often the manifestation of nonfiction, non-fictional, as well as fictional, content. The word originates from the Latin ', which denotes a "teaching" or "lesson": the verb ' 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, Computer Age, "document" usually denotes a primarily textual computer file, including its structure and format, e.g. fonts, colors, and Computer-generated imagery, 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 (library science), realia", which are three-dimensional objects that would otherwise satisfy the definition of "document" because they memorialize ... [...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 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 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] |
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
Medicine is the science and practice of caring for patients, managing the diagnosis, prognosis, prevention, treatment, palliation of their injury or disease, and promoting their health. Medicine encompasses a variety of health care practices evolved to maintain and restore health by the prevention and treatment of illness. Contemporary medicine applies biomedical sciences, biomedical research, genetics, and medical technology to diagnose, treat, and prevent injury and disease, typically through pharmaceuticals or surgery, but also through therapies as diverse as psychotherapy, external splints and traction, medical devices, biologics, and ionizing radiation, amongst others. Medicine has been practiced since prehistoric times, and for most of this time it was an art (an area of creativity and skill), frequently having connections to the religious and philosophical beliefs of local culture. For example, a medicine man would apply herbs and say prayers for healing, or an anci ... [...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] |
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] |
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) — Requireme ... [...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] |
Research And Development
Research and development (R&D or R+D), known in some countries as OKB, experiment and design, is the set of innovative activities undertaken by corporations or governments in developing new services or products. R&D constitutes the first stage of development of a potential new service or the production process. Although R&D activities may differ across businesses, the primary goal of an R&D department is to new product development, develop new products and services. 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. R&D is crucial for acquiring larger shares of the market through new products. ''R&D&I'' represents R&D with innovation. Background New product design and development is often a crucial factor in the survival of a company. In a global industrial landscape that is changing fast, firms must continually revise their design and range of ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
New Product Development
New product development (NPD) or product development in business and engineering covers the complete process of launching a new product to the market. Product development also includes the renewal of an existing product and introducing a product into a new market. A central aspect of NPD is product design. New product development is the realization of a market opportunity by making a product available for purchase. The products developed by an commercial organisation provide the means to generate income. Many technology-intensive organisations exploit technological innovation in a rapidly changing consumer market. A product can be a tangible asset or intangible. A service or user experience is intangible. In law, 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 quality are the main variables that drive customer needs. Ai ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
