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  • rachelpatel1796 replied to the topic Design input sources in the forum Introduction to Design Controls 7 years, 5 months ago

    Each manufacturer is responsible for establishing and maintained a procedure to ensure that design requirements relating to device are appropriate and address the intended use of the device. The design input requirements should be documented and approved by a designated individual. The input should require the functional and safety requirements, regulatory requirements, information derived from previous designs, and outputs of risk management. So, essentially the design inputs are very important for the making of the device. Although most people want to get their product on the market very quickly, I think more time should be spent on the design inputs and requirements since it is so important. The design inputs should take up around 30% of the project timeline. This is essential as it will build a strong foundation to ensure an easier and smoother path to market the medical device. Some good sources would be to obtain advice from a superior or those familiar with the design of your product to really ensure that it is feasible to create this project and for it to actually work effectively.