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jp582 replied to the topic Design input sources in the forum Introduction to Design Controls 8 years, 5 months ago
Design input is the key point of medical device. If design input defined well during product development, it makes the rest of product development easier. Some sources state that establishing design input can take easily up to 30% of the project timeline. Sometimes people are in a rush to get the product to market and give very little time to design input process. I think to spend a little extra time on design input process can save money and time on long run and minimize the chances of product recall. Goals of the design input should include user needs and intended use, safety, be clear and objective, comprehensive, device functions, reliability, regulatory requirements, labeling and packaging, limits, compatibility with other devices.