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23PROC013506426 20231002
1 . 4412/2016
23PROC013506426 20231002
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Design and development refer to the processes involved in creating and refining products, systems, or services, including the planning, conceptualization, prototyping, testing, and final production stages.
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Typically, businesses and organizations involved in the creation of new products or systems, especially those subjected to regulatory oversight or requiring patent protection, are required to file design and development documentation.
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To fill out the design and development documentation, one should provide detailed descriptions of the design process, methodologies used, test results, modifications made, and any compliance with applicable regulations.
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The purpose of design and development documentation is to ensure that products are created systematically, meet quality standards, comply with regulations, and can be effectively tracked from conception to completion.
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Information typically required includes project goals, design specifications, timelines, methodologies, testing results, any iterations or changes made during development, and final product evaluations.
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