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    ks629 replied to the topic Inputs for Design Input Document in the forum Project Management Process and Medical Device Development 7 years, 2 months ago

    I think we have to look at where Design Inputs come from. In medical devices Design Inputs come from the following.

    Industry standards
    Regulations
    Previous projects / products
    Competitor products
    End-users
    Prototypes

    So marketing will certainly have a role in developing the inputs by gather VOC from the end-user. As well as R&D, Regulatory, even manufacturing should have a role as the inputs may include the device manufacturability requirements. The best design inputs process will include feedback from several different functional areas.