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Independent Reviewer
An independent reviewer is an individual who does not have direct professional responsibility for the design stage under review, assuring an independent and objective review. Within the context of formal design reviews, the practical solution is simply to ensure a fresh perspective, based on the principle that those who are too close to the design may overlook design errors. Thus, reviewers should not have been significantly involved in the activities under review. US Food and Drug Administration The US Food and Drug Administration requires that developers of medical device follow a system of design controls. A key part of this system is design review, defined in 21CFR820.3 section (h) as "a documented, comprehensive, systematic examination of the design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems." In section (e), it is stated that an independent reviewer is required for any desi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Professional Responsibility
Professional responsibility is a set of duties within the concept of professional ethics for those who exercise a unique set of knowledge and skill as professionals. Professional responsibility applies to those professionals making judgments, applying their unique skills, and reaching informed decisions for, or on behalf, of others, as professionals. Professionals must be seen to exercise due care and responsibility in their areas of specialisation – known as professions. What makes professionals unique, is that the general public would not ordinarily be expected know in detail the skills and knowledge of a professions independently. In a modern context, professional responsibility encompasses an array of the personal, corporate, and humanitarian standards of behaviour, as expected by clients, fellow professionals, and professional bodies. Origins and History Professional responsibility historically applied to secularly taught professions including medicine, law, and di ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Review
A review is an evaluation of a publication, product, service, or company or a critical take on current affairs in literature, politics or culture. In addition to a critical evaluation, the review's author may assign the work a content rating, rating to indicate its relative merit. A compilation of reviews may itself be called a review. Reviews can apply to a film, movie (a Film criticism, movie review), video game (video game review), musical composition (music criticism, music review of a composition or recording), book (book review); a piece of hardware like a car, home appliance, or computer; or software such as business software, sales software; or an event or performance, such as a live concert, live music concert, Play (theatre), play, Musical theater, musical theater show, dance show or art exhibition In the cultural sphere, ''The New York Review of Books'', for instance, is a collection of essays on literature, culture, and current affairs. ''National Review'', fou ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Design
A design is a plan or specification for the construction of an object or system or for the implementation of an activity or process or the result of that plan or specification in the form of a prototype, product, or process. The verb ''to design'' expresses the process of developing a design. In some cases, the direct construction of an object without an explicit prior plan (such as in craftwork, some engineering, coding, and graphic design) may also be considered to be a design activity. The design usually has to satisfy certain goals and constraints; may take into account aesthetic, functional, economic, or socio-political considerations; and is expected to interact with a certain Environment (systems), environment. Typical examples of designs include architectural drawing, architectural and engineering drawing, engineering drawings, circuit diagrams, Pattern (sewing), sewing patterns and less tangible artefacts such as business process models. Designing People who produce designs ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Overlook
A scenic viewpoint – also called an observation point, viewpoint, viewing point, vista point, lookout, scenic overlook,These terms are more commonly used in North America. etc. – is an elevated location where people can view scenery (often with binoculars) and photograph it. Scenic viewpoints may be created alongside scenic routes or mountain roads, often as simple turnouts or lay-bys where motorists can pull over onto pavement, gravel, or grass on the right-of-way. Many viewpoints are larger, having parking areas, while some (typically on larger highways) are off the road completely. Viewing points may also be found on hill or mountain tops or on rocky spurs overlooking a valley and reached via a hiking trail. They may be protected by railings to protect the public or be enhanced by a viewing tower designed to elevate visitors above the surrounding terrain or trees in order to offer panoramic views. Overlooks are frequently found in national parks, and in the U.S. along n ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not d ... [...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] |
Design Controls
Design controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries (e.g. medical devices). Medical devices Since 1990, the Food and Drug Administration (FDA) has required that medical device manufacturers that want to market certain categories of medical devices in the USA follow Design Control requirements (21 CFR 820.30). At a high level, this regulation requires: * Design and development planning * Design input, including intended use and user needs (also known as customer attributes) * Design output, including evaluation of conformance to design input requirements through: ** Design verification confirming that the design output meets the design input requirements ("did we design the device right?") ** Design validation ensuring that the devices conform to defined user needs and intended uses ( ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Evaluate
Evaluation is a systematic determination and assessment of a subject's merit, worth and significance, using criteria governed by a set of standards. It can assist an organization, program, design, project or any other intervention or initiative to assess any aim, realisable concept/proposal, or any alternative, to help in decision-making; or to ascertain the degree of achievement or value in regard to the aim and objectives and results of any such action that has been completed. The primary purpose of evaluation, in addition to gaining insight into prior or existing initiatives, is to enable reflection and assist in the identification of future change. Evaluation is often used to characterize and appraise subjects of interest in a wide range of human enterprises, including the arts, criminal justice, foundations, non-profit organizations, government, health care, and other human services. It is long term and done at the end of a period of time. Definition Evaluation is the s ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Requirements
In product development and process optimization, a requirement is a singular documented physical or functional need that a particular design, product or process aims to satisfy. It is commonly used in a formal sense in engineering design, including for example in systems engineering, software engineering, or enterprise engineering. It is a broad concept that could speak to any necessary (or sometimes desired) function, attribute, capability, characteristic, or quality of a system for it to have value and utility to a customer, organization, internal user, or other stakeholder. Requirements can come with different levels of specificity; for example, a requirement specification or requirement "spec" (often imprecisely referred to as "the" spec/specs, but there are actually different sorts of specifications) refers to an explicit, highly objective/clear (and often quantitative) requirement (or sometimes, ''set'' of requirements) to be satisfied by a material, design, product, or serv ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Anti-terrorism Legislation
Anti-terrorism legislation are laws with the purpose of fighting terrorism. They usually, if not always, follow specific bombings or assassinations. Anti-terrorism legislation usually includes specific amendments allowing the state to bypass its own legislation when fighting terrorism-related crimes, under alleged grounds of necessity. Because of this suspension of regular procedure, such legislation is sometimes criticized as a form of ''lois scélérates'' which may unjustly repress all kinds of popular protests. Critics often allege that anti-terrorism legislation endangers democracy by creating a state of exception that allows authoritarian style of government. International conventions related to terrorism and counter-terrorism cases Terrorism has been on the international agenda since 1934, when the League of Nations, predecessor of the United Nations, began the elaboration of a convention for the prevention and punishment of terrorism. Although the convention was eventu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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