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FDA regulations have always required careful and comprehensive documentation. The FDA mentioned that there are concerns “centered on whether the program allows devices to enter the market without sufficient safety and effectiveness evidence,” according to an FDA news release. Meticulous management of design information helps a company record the safety and effectiveness of a product.
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Angiodynamics develops and markets both lasers and clinical procedure kits for medical applications. Diomed Engineers felt that new product development was being restricted by a Pro/ENGINEER System that was cumbersome to use and lacked the intuitive power of modern systems.
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Wellingborough company, ESTS (GB) Ltd, have announced their recent acquisition of SolidWorks, an advanced 3D engineering design software that enables engineers to create virtual 3D models of their designs and to generate detailed manufacturing data.
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