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  • sp2387 replied to the topic Design Change Request in the forum Project Management Process and Medical Device Development 6 years, 2 months ago

    The project manager, system analyst and the device designer all should review each proposed designs and change according to what action is needed.

    The following topics should also be considered:

    Design change and its cost effects.

    Timeline affected due to changes.

    Functional and structural change necessity.

    According to aforementioned point the design change request should be considered.