here are no regulatory requirements

here are no regulatory requirements to have a Design Space Quality Risk Management approaches need to be considered to ensure the robustness of the Design SpaceDesign space can illustrate understanding of parameter interactions and provides manufacturing flexibilityProven acceptable range alone is not a design spaceDesign space can include critical and non-critical parametersDesign space should be verified and opperational at full scaleNo requirement to develop a design space at the full manufacturing scale Many options exist for how (and where) to present a design space