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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.
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Download as PDF; Printable version ... 1QFY02 Successful preliminary design review. ... Thomas E. White to discuss defense spending cuts to free funding for more ...
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 Navy did not issue any aircraft performance specifications or draft requirements until the spring of 2013, so competitors tried to refit their aircraft for the preliminary design review phase. The lack of feedback was compounded by the shift of mission statements, from a long-range penetrating strike platform to long-duration orbits over ...
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
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]
The preliminary design review was originally planned to be completed by June 2017. [5] While NASA received three inquiries for its August 2017 request for proposals, Lockheed was the sole bidder. [6] On April 2, 2018, NASA awarded Lockheed Martin a $247.5 million contract to design, build and deliver in late 2021 the Low-Boom X-plane.