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In 21CFR820.3(h), design review is described as "documented, comprehensive, systematic examination of the design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems". The FDA also specifies that a design review should include an independent reviewer.
A design review is a milestone within a product development process whereby a design is evaluated against its requirements in order to verify the outcomes of previous activities and identify issues before committing to—and, if need be, to re-prioritise—further work. [1]
Work breakdown structures that subdivide work by project phases (e.g. preliminary design phase, critical design phase) must ensure that phases are clearly separated by a deliverable also used in defining entry and exit criteria (e.g., an approved preliminary or critical design review).
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The preliminary design review evaluates the adequacy of the preliminary design. In the following phase, detailed design is drawn and coded for the system as a whole and all the subsystems, and a critical design review is performed where it is evaluated whether the design is sufficiently detailed to fabricate, integrate, and test the system. [1] [2]
Design and development planning; Design input, including intended use and user needs (also known as customer attributes) Design output, including evaluation of conformance to design input requirements through: Design verification confirming that the design output meets the design input requirements ("did we design the device right?")
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The SDR is a technical review conducted to evaluate the manner in which a project's system requirements have been allocated to configuration items, manufacturing considerations, next phase planning, production plans, and the engineering process that produced the allocation. This review is conducted when the system definition is at a point where ...