Design controls are a set of quality practices and procedures that are incorporated into the product design and development process to ensure that a device is appropriate for its intended use. Essentially, design control consists of planning, design execution, testing against specifications (inputs) and requirements (user needs), and uncovering and fixing problems at an early stage (risk reduction).
The key elements of design control are:
*Source: https://www.proximacro.com
Design control documents include product design and development plans, drawings, design specifications, manufacturing instructions, component specifications, and assembly instructions.
*Source: https://www.proximacro.com
Design Controls, which are a systematic technique for developing Class II and Class III medical devices, are required by the FDA. This approach necessitates multiple layers of paperwork to show the FDA how you ensured the safety and efficacy of your medical device.
*Source: https://www.mindflowdesign.com
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