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msc52njit-edu replied to the topic What are Design Controls? in the forum Introduction to Design Controls 6 years, 9 months ago
Design Controls are a critical component of every project and provide the necessary checks to ensure that all devices are safe for use and meet their intended use. Design Controls will monitor the steps that you take in designing and creating your device to ensure that no necessary steps are skipped, that enough time is taken on each step to ensure completeness and accuracy and that everyone is following the same procedure to keep everything regulated. Documents such as the DDP, DID and DSD help project teams by making them clarify exactly what they need out of their device, to help them set their own standards that the FDA believes to be necessary, and helps keep project teams organized. By making project teams stay extremely organized, all important and useful information can be used to verify and validate the device, and can be used to eliminate potentially dangerous of useless devices. These documents make it easier for the FDA to approve devices as they have a template to matchup and compare your device too. This order makes it so devices can get approved quicker and can be put out on the market quicker. It also ensures safety with multiple documents and checks along the design process to make sure the device will not injury or cause harm to the patients.