Design Review
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Design Review
A design review is a milestone within a product development process whereby a design is evaluated against its requirements in order to verify the outcomes of previous activities and identify issues before committing to—and, if need be, to re-prioritise—further work. The ultimate design review, if successful, therefore triggers the product launch or product release. The conduct of design reviews is compulsory as part of design controls, when developing products in certain regulated contexts such as medical devices. By definition, a review must include persons who are external to the design team. Contents of a design review In order to evaluate a design against its requirements, a number of means may be considered, such as: *Physical tests. *Engineering simulations. *Examinations (Walk-through). Timing of design reviews Most formalised systems engineering processes recognise that the cost of correcting a fault increases as it progresses through the development process. Addi ...
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United States Department Of Defense
The United States Department of Defense (DoD, USDOD or DOD) is an executive branch department of the federal government charged with coordinating and supervising all agencies and functions of the government directly related to national security and the United States Armed Forces. The DoD is the largest employer in the world, with over 1.34 million active-duty service members (soldiers, marines, sailors, airmen, and guardians) as of June 2022. The DoD also maintains over 778,000 National Guard and reservists, and over 747,000 civilians bringing the total to over 2.87 million employees. Headquartered at the Pentagon in Arlington, Virginia, just outside Washington, D.C., the DoD's stated mission is to provide "the military forces needed to deter war and ensure our nation's security". The Department of Defense is headed by the secretary of defense, a cabinet-level head who reports directly to the president of the United States. Beneath the Department of Defense are th ...
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NASA
The National Aeronautics and Space Administration (NASA ) is an independent agency of the US federal government responsible for the civil space program, aeronautics research, and space research. NASA was established in 1958, succeeding the National Advisory Committee for Aeronautics (NACA), to give the U.S. space development effort a distinctly civilian orientation, emphasizing peaceful applications in space science. NASA has since led most American space exploration, including Project Mercury, Project Gemini, the 1968-1972 Apollo Moon landing missions, the Skylab space station, and the Space Shuttle. NASA supports the International Space Station and oversees the development of the Orion spacecraft and the Space Launch System for the crewed lunar Artemis program, Commercial Crew spacecraft, and the planned Lunar Gateway space station. The agency is also responsible for the Launch Services Program, which provides oversight of launch operations and countdown management f ...
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Product Development
In business and engineering, new product development (NPD) covers the complete process of bringing a new 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 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 quality are the main variables that driv ...
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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 ...
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Requirements Analysis
In systems engineering and software engineering, requirements analysis focuses on the tasks that determine the needs or conditions to meet the new or altered product or project, taking account of the possibly conflicting requirements of the various stakeholders, ''analyzing, documenting, validating and managing'' software or system requirements. Requirements analysis is critical to the success or failure of a systems or software project. The requirements should be documented, actionable, measurable, testable, traceable, related to identified business needs or opportunities, and defined to a level of detail sufficient for system design. Overview Conceptually, requirements analysis includes three types of activities: * Eliciting requirements: (e.g. the project charter or definition), business process documentation, and stakeholder interviews. This is sometimes also called requirements gathering or requirements discovery. *Recording requirements: Requirements may be document ...
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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 ( ...
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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 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& ...
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Systems Engineering Process
Systems engineering is an interdisciplinary field of engineering and engineering management that focuses on how to design, integrate, and manage complex systems over their enterprise life cycle, life cycles. At its core, systems engineering utilizes systems thinking principles to organize this body of knowledge. The individual outcome of such efforts, an engineered system, can be defined as a combination of components that work in synergy to collectively perform a useful Function (engineering), function. Issues such as requirements engineering, reliability, logistics, coordination of different teams, testing and evaluation, maintainability and many other Discipline (academia), disciplines necessary for successful system design, development, implementation, and ultimate decommission become more difficult when dealing with large or complex projects. Systems engineering deals with work-processes, optimization methods, and risk management tools in such projects. It overlaps technical ...
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Systems Development Life Cycle
In systems engineering, information systems and software engineering, the systems development life cycle (SDLC), also referred to as the application development life cycle, is a process for planning, creating, testing, and deploying an information system. The systems development life cycle concept applies to a range of hardware and software configurations, as a system can be composed of hardware only, software only, or a combination of both. There are usually six stages in this cycle: requirement analysis, design, development and testing, implementation, documentation, and evaluation. Overview A systems development life cycle is composed of a number of clearly defined and distinct work phases which are used by systems engineers and systems developers to plan for, design, build, test, and deliver information systems. Like anything that is manufactured on an assembly line, an SDLC aims to produce high-quality systems that meet or exceed customer expectations, based on customer ...
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Usability
Usability can be described as the capacity of a system to provide a condition for its users to perform the tasks safely, effectively, and efficiently while enjoying the experience. In software engineering, usability is the degree to which a software can be used by specified consumers to achieve quantified objectives with effectiveness, efficiency, and satisfaction in a quantified context of use. The object of use can be a software application, website, book, tool, machine, process, vehicle, or anything a human interacts with. A usability study may be conducted as a primary job function by a ''usability analyst'' or as a secondary job function by designers, technical writers, marketing personnel, and others. It is widely used in consumer electronics, communication, and knowledge transfer objects (such as a cookbook, a document or online help) and mechanical objects such as a door handle or a hammer. Usability includes methods of measuring usability, such as needs analysis and t ...
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Language Localisation
Language localisation (or language localization) is the process of adapting a product's translation to a specific country or region. It is the second phase of a larger process of product translation and cultural adaptation (for specific countries, regions, cultures or groups) to account for differences in distinct markets, a process known as internationalization and localization, internationalisation and localisation. Language localisation differs from Translation, translation activity because it involves a comprehensive study of the target culture in order to correctly adapt the product to local needs. Localisation can be referred to by the numeronym L10N (as in: "L", followed by the number 10, and then "N"). The localisation process is most generally related to the cultural adaptation and translation of software localization, software, video game localization, video games, websites, and technical communication, as well as audio/voiceover, video, or other multimedia content, and ...
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Design Review (U
A design review is a milestone within a product development process whereby a design is evaluated against its requirements in order to verify the outcomes of previous activities and identify issues before committing to—and, if need be, to re-prioritise—further work. The ultimate design review, if successful, therefore triggers the product launch or product release. The conduct of design reviews is compulsory as part of design controls, when developing products in certain regulated contexts such as medical devices. By definition, a review must include persons who are external to the design team. Contents of a design review In order to evaluate a design against its requirements, a number of means may be considered, such as: *Physical tests. *Engineering simulations. *Examinations (Walk-through). Timing of design reviews Most formalised systems engineering processes recognise that the cost of correcting a fault increases as it progresses through the development process. Addi ...
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