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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.
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).
The ultimate design review, if successful, therefore triggers the product launch or product release. The conduct of design reviews is compulsory as part of design controls, when developing products in certain regulated contexts such as medical devices. By definition, a review must include persons who are external to the design team.
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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 ...
Design review; Design transfer ensuring that the device design is correctly translated into production specifications; Design changes; Design history file, a demonstration that the design was developed according to the approved design plan and 21 CFR 820.30.
The US Food and Drug Administration requires that developers of medical device follow a system of design controls.A key part of this system is design review, defined in 21CFR820.3 section (h) as "a 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 ...
The engineering design process, also known as the engineering method, is a common series of steps that engineers use in creating functional products and processes. The process is highly iterative – parts of the process often need to be repeated many times before another can be entered – though the part(s) that get iterated and the number of such cycles in any given project may vary.