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  • nda4 replied to the topic What are Design Controls? in the forum Introduction to Design Controls 8 years, 7 months ago

    Hi Grzegorz, it is true like you have said that design control is important in order to ensure quality and correct errors. It is also important to note that design controls are required for all Class II and Class III medical devices developed in the US as part of the Quality Management System (QMS) and IDE. Also, it is important to note, that experts suggest keeping a developmental plan high level and short in order to not overcommit. According to the CFR, Design inputs must be unambiguous and verifiable.