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  • Devarshi Joshi replied to the topic What are Design Controls? in the forum Introduction to Design Controls 6 years, 5 months ago

    Set of quality practices and process are defined as design controls. To assure that it meets user needs, intended use and requirements. It monitors and ensures no steps are skipped and enough amount of time is given to each step to complete accurately. Some documents like DID, DSD, etc helps teams clarifying the needs and provide the exact product. By making teams all important information is validated and verified and helps in eliminating dangers. And so these things makes easy for FDA to approve any devices. This helps for a device to get approved quicker and sent to the market quicker.