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Download as PDF; Printable version; In other projects Appearance. ... Redirect page. Redirect to: Design review (U.S. government)#Preliminary Design Review (PDR)
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.
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.
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 ...
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Preliminary Design Review, a step in the engineering design process Purchase of development rights — see Conservation easement Petition for Discretionary Review - In appellate law, a way of seeking review by a higher court when no appeal of right exists
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?")